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 administrationInitial U.S. Approval: 1987
Approved
Approval ID
273c6f4d-604f-4797-8961-c5f918542e3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2015
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc
DUNS: 937890044
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 Code63304-875
Application NumberANDA077974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Amlodipine Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-874
Application NumberANDA077974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Amlodipine Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-873
Application NumberANDA077974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT