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 USP, for oral administrationInitial U.S. Approval: 1987
Approved
Approval ID
04809c4e-ae49-4c0b-92e2-123156bd8eab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2016
Manufacturers
FDA
Central Texas Community Health Centers
DUNS: 079674019
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 Code76413-141
Application NumberANDA078226
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2016
FDA Product Classification
INGREDIENTS (5)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT