FDA Product

Bumetanide

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

Basic Information

Product Name

Bumetanide

FDA Product Code

72162-2196

Regulatory Information

NDC Product Code

72162-2196

Application Number

ANDA074700

Marketing Category

C73584

Effective Date

January 26, 2024

Territorial Authority

USA

FDA Title

Bumetanide Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

102

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

Quantity: 1 mg in 1 1

Code: 0Y2S3XUQ5H

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Active Moieties

BUMETANIDE

Code: 0Y2S3XUQ5H

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