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: 1992
Approved
Approval ID
0c5784b9-5542-144f-e063-6394a90a7ebc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
Products 1
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 Code51655-044
Application NumberANDA077073
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMLODIPINE BESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM