Amlodipine Besylate
These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administrationInitial U.S. Approval: 1987
Approved
Approval ID
eefd43c3-028c-43d6-aa51-26d7157ea8f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 2
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 Code10544-113
Application NumberANDA077955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2015
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
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 Code10544-112
Application NumberANDA077955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2015
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
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