NDC Code(s) : 0032-1203-70, 0032-1203-64, 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212-46, 0032-1212-13, 0032-1224-07, 0032-1224-01, 0032-1224-46, 0032-3016-28, 0032-3016-13, 0032-3016-50, 0032-3016-12, 0032-0045-70, 0032-0045-30, 0032-0046-30, 0032-0046-70, 0032-0047-30, 0032-0047-70, 0032-2636-70, 0032-2636-01, 0032-2636-30, 0032-2637-70, 0032-2637-01, 0032-2637-30
Packager : AbbVie Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CreonPancrelipase CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE15000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE3000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE9500 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
Product Characteristics
Color white (White opaque body and white opaque cap) Score no score
Shape CAPSULE (OVAL) Size 14 mm
Flavor Imprint Code CREON;1203
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1203-701 in 1 CARTON 30/04/2009
170 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0032-1203-641 in 1 CARTON 30/04/2009
270 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 04/30/2009
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1206
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE30000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE6000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE19000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color blue (Blue opaque body), orange (Orange opaque cap) Score no score
Shape CAPSULE (OVAL) Size 14 mm
Flavor Imprint Code CREON;1206
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1206-07250 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
2NDC:0032-1206-011 in 1 CARTON 30/04/2009
2100 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
3NDC:0032-1206-561 in 1 CARTON 30/04/2009
3100 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 04/30/2009
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1212
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE60000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE12000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE38000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown (Colorless transparent body and brown opaque cap) Score no score
Shape CAPSULE (OVAL) Size 18 mm
Flavor Imprint Code CREON;1212
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1212-07250 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
2NDC:0032-1212-01100 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
3NDC:0032-1212-461 in 1 CARTON 30/04/2009
312 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
4NDC:0032-1212-131 in 1 CARTON 20/11/2018
4100 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 04/30/2009
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1224
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE24000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE76000 [USP'U]
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE120000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color orange (Colorless transparent body and orange opaque cap) Score no score
Shape CAPSULE (OVAL) Size 22 mm
Flavor Imprint Code CREON;1224
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1224-07250 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
2NDC:0032-1224-01100 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
3NDC:0032-1224-461 in 1 CARTON 30/04/2009
312 in 1 BOTTLE Type 0: Not a Combination Product30/04/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 04/30/2009
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-3016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE36000 [USP'U]
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE180000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE114000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue (Colorless transparent body and blue opaque cap) Score no score
Shape CAPSULE (OVAL) Size 25 mm
Flavor Imprint Code CREON;1236
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-3016-28250 in 1 BOTTLE Type 0: Not a Combination Product14/03/2013
2NDC:0032-3016-13100 in 1 BOTTLE Type 0: Not a Combination Product14/03/2013
3NDC:0032-3016-5050 in 1 BOTTLE Type 0: Not a Combination Product14/03/2013
4NDC:0032-3016-121 in 1 CARTON 14/03/2013
412 in 1 BOTTLE Type 0: Not a Combination Product14/03/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 03/14/2013
CreonPancrelipase CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-0045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE15000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE3000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE9500 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
Product Characteristics
Color white (White opaque body and white opaque cap) Score no score
Shape CAPSULE (OVAL) Size 14 mm
Flavor Imprint Code CREON;1203
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-0045-7070 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
2NDC:0032-0045-3070 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 10/12/2023
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-0046
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE30000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE6000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE19000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color blue (Blue opaque body), orange (Orange opaque cap) Score no score
Shape CAPSULE (OVAL) Size 14 mm
Flavor Imprint Code CREON;1206
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-0046-30100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
2NDC:0032-0046-70100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 10/12/2023
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-0047
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE60000 [USP'U]
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE12000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE38000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown (Colorless transparent body and brown opaque cap) Score no score
Shape CAPSULE (OVAL) Size 18 mm
Flavor Imprint Code CREON;1212
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-0047-30100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
2NDC:0032-0047-70100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 10/12/2023
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-2636
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE24000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE76000 [USP'U]
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE120000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color orange (Colorless transparent body and orange opaque cap) Score no score
Shape CAPSULE (OVAL) Size 22 mm
Flavor Imprint Code CREON;1224
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-2636-70240 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
2NDC:0032-2636-01100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
3NDC:0032-2636-3024 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 10/12/2023
CreonPancrelipase CAPSULE, DELAYED RELEASE PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-2637
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
(PANCRELIPASE LIPASE - UNII:8MYC33932O) 		PANCRELIPASE LIPASE36000 [USP'U]
PANCRELIPASE AMYLASE(UNII: YOJ58O116E)
(PANCRELIPASE AMYLASE - UNII:YOJ58O116E) 		PANCRELIPASE AMYLASE180000 [USP'U]
PANCRELIPASE PROTEASE(UNII: 3560D81V50)
(PANCRELIPASE PROTEASE - UNII:3560D81V50) 		PANCRELIPASE PROTEASE114000 [USP'U]
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CARRAGEENAN(UNII: 5C69YCD2YJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue (Colorless transparent body and blue opaque cap) Score no score
Shape CAPSULE (OVAL) Size 25 mm
Flavor Imprint Code CREON;1236
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-2637-70240 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
2NDC:0032-2637-01100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
3NDC:0032-2637-301 in 1 CARTON 10/12/2023
324 in 1 BOTTLE Type 0: Not a Combination Product10/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020725 10/12/2023

LABELER - AbbVie Inc.(078458370)

PRINCIPAL DISPLAY PANEL

NDC 0032-0045-70
70 Delayed-Release Capsules
Rx only
pancrelipase
CREON ®
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 3,000 USP Units
Protease 9,500 USP Units
Amylase 15,000 USP Units
Each delayed-release capsule contains
pancrelipase in enteric-coasted spheres.
Dispense enclosed Medication Guide to each patient.

NDC 0032-0045-70 70 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coasted spheres. Dispense enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL

NDC 0032-0046-70
100 Delayed-Release Capsules
Rx only
pancrelipase
CREON ®
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 6,000 USP Units
Protease 19,000 USP Units
Amylase 30,000 USP Units
Each delayed-release capsule contains
pancrelipase in enteric-coasted spheres.
Dispense enclosed Medication Guide to each patient.

NDC 0032-0046-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coasted spheres. Dispense enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL

NDC 0032-0047-70
100 Delayed-Release Capsules
Rx only
pancrelipase
CREON ®
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 12,000 USP Units
Protease 38,000 USP Units
Amylase 60,000 USP Units
Each delayed-release capsule contains
pancrelipase in enteric-coasted spheres.
Dispense enclosed Medication Guide to each patient.

NDC 0032-0047-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coasted spheres. Dispense enclosed Medication Guide to each patient.

PRINCIPAL DISPLAY PANEL

NDC 0032-1203-70
70 Delayed-Release Capsules
Pancrelipase
CREON ®   
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 3,000 USP Units
Protease 9,500 USP Units
Amylase 15,000 USP Units
Each delayed-release capsule
contains pancrelipase in
enteric-coated spheres.
Dispense enclosed Medication
Guide to each patient.
Rx only
abbvie

NDC 0032-1203-70 70 Delayed-Release Capsules Pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-1206-01
100 Delayed-Release Capsules
pancrelipase
CREON ®   
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 6,000 USP Units
Protease 19,000 USP Units
Amylase 30,000 USP Units
Each delayed-release capsule contains
pancrelipase in enteric-coated spheres.
Dispense enclosed Medication
Guide to each patient.
Rx only
abbvie

NDC 0032-1206-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-1212-07
250 Delayed-Release Capsules
pancrelipase
CREON ®  
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 12,000 USP Units
Protease 38,000 USP Units
Amylase 60,000 USP Units
Each delayed-release capsule
contains pancrelipase in
enteric-coated spheres.
Dispense enclosed
Medication Guide
to each patient.
Rx only
abbvie

NDC 0032-1212-07 250 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-1224-01
100 Delayed-Release Capsules
pancrelipase
CREON ®  
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 24,000 USP Units
Protease 76,000 USP Units
Amylase 120,000 USP Units
Each delayed-release capsule
contains pancrelipase in
enteric-coated spheres.
Dispense enclosed
Medication Guide
to each patient.
Rx only
abbvie

NDC 0032-1224-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-2636-70
240 Delayed-Release Capsules
pancrelipase
CREON ®
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 24,000 USP Units
Protease 76,000 USP Units
Amylase 120,000 USP Unites
Each delayed-release capsule contains
pancrelipase in enteric-coasted spheres.
Dispense enclosed Medication Guide to each patient.
Rx only
Abbvie

NDC 0032-2636-70 240 Delayed-Release Capsules Pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coasted spheres. Dispense enclosed Medication Guide to each patient. Rx only Abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-2637-70
240 Delayed-Release Capsules
pancrelipase
CREON ®
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 36,000 USP Units
Protease 114,000 USP Units
Amylase 180,000 USP Unites
Each delayed-release capsule contains
pancrelipase in enteric-coasted spheres.
Dispense enclosed Medication
Guide to each patient.
Rx only
Abbvie

NDC 0032-2637-70 240 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coasted spheres. Dispense enclosed Medication Guide to each patient. Rx only Abbvie

PRINCIPAL DISPLAY PANEL

NDC 0032-3016-13
100 Delayed-Release Capsules
pancrelipase
CREON ®
Delayed-Release Capsules
CREON® (pancrelipase)
Delayed-Release Capsules
DOSE BY LIPASE UNITS:
Lipase 36,000 USP Units
Protease 114,000 USP Units
Amylase 180,000 USP Units
Each delayed-release capsule
contains pancrelipase in
enteric-coated spheres.
Dispense enclosed
Medication Guide
to each patient.
Rx only
abbvie

NDC 0032-3016-13 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules CREON® (pancrelipase) Delayed-Release Capsules DOSE BY LIPASE UNITS: Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie