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Furosemide

FUROSEMIDE TABLETS, USP 20 mg, 40 mg and 80 mg

Approved
Approval ID

33ec71e2-8fbd-0703-e063-6294a90a62e1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 29, 2025

Manufacturers
FDA

Coupler LLC

DUNS: 119003108

Products 1

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

Furosemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-1555
Application NumberANDA077293
Product Classification
M
Marketing Category
C73584
G
Generic Name
Furosemide
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification

INGREDIENTS (7)

FUROSEMIDEActive
Quantity: 80 mg in 1 1
Code: 7LXU5N7ZO5
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Furosemide - FDA Drug Approval Details