PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1204-5

Candesartan Cilexetil Tablets USP, 4 mg

Rx Only

500 tablets

NDC 70771-1205-5

Candesartan Cilexetil Tablets USP, 8 mg

Rx Only

500 tablets

NDC 70771-1206-5

Candesartan Cilexetil Tablets USP, 16 mg

Rx Only

500 tablets

NDC 70771-1207-5

Candesartan Cilexetil Tablets USP, 32 mg

Rx Only

500 tablets

CANDESARTAN CILEXETIL
candesartan cilexetil tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1204
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)	CANDESARTAN CILEXETIL	4 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK (LIGHT PINK)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZE;58
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1204-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
2	NDC:70771-1204-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
3	NDC:70771-1204-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091390	02/22/2018

CANDESARTAN CILEXETIL
candesartan cilexetil tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1205
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)	CANDESARTAN CILEXETIL	8 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK (PINK)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZE;59
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1205-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
2	NDC:70771-1205-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
3	NDC:70771-1205-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091390	02/22/2018

CANDESARTAN CILEXETIL
candesartan cilexetil tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1206
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)	CANDESARTAN CILEXETIL	16 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZE;60
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1206-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
2	NDC:70771-1206-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
3	NDC:70771-1206-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
4	NDC:70771-1206-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
5	NDC:70771-1206-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091390	02/22/2018

CANDESARTAN CILEXETIL
candesartan cilexetil tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1207
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)	CANDESARTAN CILEXETIL	32 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	ZE;61
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1207-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
2	NDC:70771-1207-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
3	NDC:70771-1207-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
4	NDC:70771-1207-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018
5	NDC:70771-1207-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091390	02/22/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1204, 70771-1205, 70771-1206, 70771-1207) , MANUFACTURE(70771-1204, 70771-1205, 70771-1206, 70771-1207)

CANDESARTAN CILEXETIL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL