NDC Code(s) : 69097-913-02, 69097-913-12, 69097-914-02, 69097-914-12
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

omeprazole sodium bicarbonateomeprazole sodium bicarbonate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-913
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE20 mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20) 		SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SODIUM(UNII: 9NEZ333N27)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
AMMONIA(UNII: 5138Q19F1X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Product Characteristics
Color WHITE (white to off wihte) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code SG;363
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-913-0230 in 1 BOTTLE Type 0: Not a Combination Product30/01/2017
2NDC:69097-913-12500 in 1 BOTTLE Type 0: Not a Combination Product30/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207476 01/30/2017
omeprazole sodium bicarbonateomeprazole sodium bicarbonate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-914
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE40 mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20) 		SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
AMMONIA(UNII: 5138Q19F1X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code SG;364
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-914-0230 in 1 BOTTLE Type 0: Not a Combination Product30/01/2017
2NDC:69097-914-12500 in 1 BOTTLE Type 0: Not a Combination Product30/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207476 01/30/2017

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - sciegenpharma(079391286)

Establishment
Name Address ID/FEI Business Operations
sciegenpharma 079391286 ANALYSIS(69097-913, 69097-914), LABEL(69097-913, 69097-914), MANUFACTURE(69097-913, 69097-914), PACK(69097-913, 69097-914)

PRINCIPAL DISPLAY PANEL

69097-913-02                   Rx only

Omeprazole

and Sodium

Bicarbonate

Capsules

20 mg/1100 mg

PHARMACIST:

Dispense the accompanying

Medication Guide to each patient.

30 capsules

20mg30s20mg30s

69097-914-02                  Rx only

Omeprazole

and Sodium

Bicarbonate

Capsules

40 mg/1100 mg

PHARMACIST:

Dispense the accompanying

Medication Guide to each patient.

30 capsules

20mg30s