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
6c75cd90-7dac-4876-bfbd-50d842176475
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0673
Application NumberNDA019787
Product Classification
M
Marketing Category
C73605
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2011
FDA Product Classification
INGREDIENTS (5)
amlodipine besylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
anhydrous dibasic calcium phosphateInactive
Code: L11K75P92J
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT