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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

2cdd0da9-eea6-45e0-b0b7-35413a168a4f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 8, 2023

Manufacturers
FDA

Legacy Pharmaceutical Packaging, LLC

DUNS: 143213275

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

NDC Product Code68645-516
Application NumberANDA077955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameAmlodipine Besylate

INGREDIENTS (5)

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
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM

Amlodipine Besylate

PRODUCT DETAILS

NDC Product Code68645-515
Application NumberANDA077955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameAmlodipine Besylate

INGREDIENTS (5)

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
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM

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Amlodipine Besylate - FDA Drug Approval Details