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
9f327d08-7661-4088-b554-2f9a99a113e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2020
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-488
Application NumberANDA078925
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2020
FDA Product Classification
INGREDIENTS (6)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT