SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-620-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

Rx only

90 tablets

NDC 65841-621-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 5 mg

Rx only

90 tablets

NDC 65841-622-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 10 mg

Rx only

90 tablets

AMLODIPINE BESYLATE
amlodipine besylate tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-620-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
2	NDC:65841-620-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
3	NDC:65841-620-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
4	NDC:65841-620-77	10 in 1 CARTON	09/21/2007
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078226	09/21/2007

AMLODIPINE BESYLATE
amlodipine besylate tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-621-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
2	NDC:65841-621-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
3	NDC:65841-621-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
4	NDC:65841-621-77	10 in 1 CARTON	09/21/2007
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078226	09/21/2007

AMLODIPINE BESYLATE
amlodipine besylate tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-622-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
2	NDC:65841-622-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
3	NDC:65841-622-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2007
4	NDC:65841-622-77	10 in 1 CARTON	09/21/2007
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078226	09/21/2007

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)