NDC Code(s) : 49884-658-09, 49884-659-09, 49884-660-09, 49884-661-09
Packager : Par Pharmaceutical Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Candesartan cilexetilCandesartan cilexetil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL4 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (circular biconvex shaped) Size 7 mm
Flavor Imprint Code ACF;004
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-658-0990 in 1 BOTTLE Type 0: Not a Combination Product21/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020838 05/21/2013 12/31/2025
Candesartan cilexetilCandesartan cilexetil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-659
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL8 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (light pink) Score 2 pieces
Shape ROUND (circular biconvex-sharped) Size 7 mm
Flavor Imprint Code ACG;008
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-659-0990 in 1 BOTTLE Type 0: Not a Combination Product21/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020838 05/21/2013 04/30/2026
Candesartan cilexetilCandesartan cilexetil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-660
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL16 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (circular biconvex shaped) Size 7 mm
Flavor Imprint Code ACH;016
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-660-0990 in 1 BOTTLE Type 0: Not a Combination Product21/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020838 05/21/2013 01/31/2026
Candesartan cilexetilCandesartan cilexetil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-661
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL32 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND (circular; biconvex-shaped) Size 10 mm
Flavor Imprint Code ACL;032
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-661-0990 in 1 BOTTLE Type 0: Not a Combination Product21/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020838 05/21/2013 08/31/2025

LABELER - Par Pharmaceutical Inc.(092733690)

PRINCIPAL DISPLAY PANEL

NDC 49884-658-09          90 Tablets

Candesartan

Cilexetil

4 mg tablets

Rx only

Mfg. by: AstraZeneca AB

S-151 85 Södertälje, Sweden

Mfd. For: Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Product of Italy

PAR PHARMACEUTICAL

4 mg 90 tablets

PRINCIPAL DISPLAY PANEL

NDC 49884-659-09     90 Tablets

Candesartan

Cilexetil

8 mg tablets

Rx only

Mfg. by: AstraZeneca AB

S-151 85 Södertälje, Sweden

Mfd. For: Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Product of Italy

PAR PHARMACEUTICAL

8 mg 90 tablets

PRINCIPAL DISPLAY PANEL

NDC 49884-660-09     90 tablets

Candesartan

Cilexetil

16 mg tablets

Rx only

Mfg. by: AstraZeneca AB

S-151 85 Södertälje, Sweden

Mfd. For: Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Product of Italy

PAR PHARMACEUTICAL

16 mg 90 tablets

PRINCIPAL DISPLAY PANEL

NDC 49884-661-09     90 tablets

Candesartan

Cilexetil

32 mg tablets

Rx only

Mfg. by: AstraZeneca AB

S-151 85 Södertälje, Sweden

Mfd. For: Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Product of Italy

PAR PHARMACEUTICAL

32 mg 90 tablets