PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-616-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 3.125 mg

Rx only

100 Tablets

NDC 65841-617-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 6.25 mg

Rx only

100 Tablets

NDC 65841-618-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 12.5 mg

Rx only

100 Tablets

NDC 65841-619-01 in bottle of 100 Tablets

Carvedilol Tablets USP, 25 mg

Rx only

100 Tablets

CARVEDILOL
carvedilol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-616
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)	CARVEDILOL	3.125 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	4mm
Flavor		Imprint Code	Z;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-616-17	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
2	NDC:65841-616-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
3	NDC:65841-616-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077614	09/05/2007

CARVEDILOL
carvedilol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-617
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)	CARVEDILOL	6.25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZC40
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-617-17	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
2	NDC:65841-617-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
3	NDC:65841-617-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077614	09/05/2007

CARVEDILOL
carvedilol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-618
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)	CARVEDILOL	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	ZC41
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-618-17	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
2	NDC:65841-618-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
3	NDC:65841-618-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077614	09/05/2007

CARVEDILOL
carvedilol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-619
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)	CARVEDILOL	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZC42
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-619-17	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
2	NDC:65841-619-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007
3	NDC:65841-619-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077614	09/05/2007

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619)

CARVEDILOL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL