FDA Product

bumetanide

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

Basic Information

Product Name

bumetanide

FDA Product Code

14539-701

Regulatory Information

NDC Product Code

14539-701

Application Number

ANDA074225

Marketing Category

C73584

Effective Date

September 21, 2020

Territorial Authority

USA

FDA Title

Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DUNS Number

780779901

Active Ingredients

Quantity: 1 mg in 1 1

Code: 0Y2S3XUQ5H

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

BUMETANIDE

Code: 0Y2S3XUQ5H

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