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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 use Initial U.S. Approval: 1992

Approved
Approval ID

eb82ef86-51f9-dd36-e053-2a95a90aa5eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 15, 2022

Manufacturers
FDA

Marlex Pharmaceuticals, Inc.

DUNS: 782540215

Products 3

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 Code10135-760
Application NumberANDA207821
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2022
FDA Product Classification

INGREDIENTS (5)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM

amlodipine besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10135-759
Application NumberANDA207821
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2022
FDA Product Classification

INGREDIENTS (5)

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
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 Code10135-761
Application NumberANDA207821
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2022
FDA Product Classification

INGREDIENTS (5)

AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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