FDA Product

ENALAPRIL MALEATE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

ENALAPRIL MALEATE

FDA Product Code

63304-525

Regulatory Information

NDC Product Code

63304-525

Application Number

ANDA075556

Marketing Category

C73584

Effective Date

April 26, 2016

Territorial Authority

USA

FDA Title

ENALAPRIL MALEATE TABLETS USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerRanbaxy Pharmaceuticals Inc.

DUNS Number

937890044

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ENALAPRIL MALEATE

Quantity: 20 mg in 1 1

Code: 9O25354EPJ

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

ZINC STEARATE

Code: H92E6QA4FV

Class Code: IACT

MALEIC ACID

Code: 91XW058U2C

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

ENALAPRILAT ANHYDROUS

Code: Q508Q118JM

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