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Bumetanide

Bumetanide Tablets USP

Approved
Approval ID

ac9bfd0e-8687-464e-a8df-793868053d28

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 21, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bumetanide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-1744
Application NumberANDA074700
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification

INGREDIENTS (7)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUMETANIDEActive
Quantity: 1 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

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Bumetanide - FDA Drug Approval Details