Amlodipine Besylate
These highlights do not include all the information needed to use amlodipine besylate tabletssafely and effectively. See full prescribing information for amlodipine besylate tablets.Amlodipine Besylate Tablets, USP for oral administrationInitial U.S. Approval: 1987
Approved
Approval ID
42881d5b-7e35-496e-aeeb-8da760d4267c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2012
Manufacturers
FDA
Caraco Pharmaceutical Laboratories, Ltd.
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-055
Application NumberANDA078552
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-056
Application NumberANDA078552
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-057
Application NumberANDA078552
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT