AMLODIPINE BESYLATE
These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets for oral administration Initial U.S. Approval: 1987
Approved
Approval ID
a3294d91-4aa9-4a94-be6a-28ccf2d74326
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2011
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
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 Code55648-422
Application NumberANDA078500
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification
INGREDIENTS (7)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-423
Application NumberANDA078500
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification
INGREDIENTS (7)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMLODIPINE BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-421
Application NumberANDA078500
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification
INGREDIENTS (7)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT