Viewing data from:

FUROSEMIDE

NDA

FUROSEMIDE | N018569 | EPIC PHARMA LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$0.0498

per ea

Lowest NADAC/Unit

$0.0249

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
63561016605FUROSEMIDE 80 MG TABLET	$0.0498	EA	Generic	—	2026-10-21
63561016502FUROSEMIDE 40 MG TABLET	$0.0288	EA	Generic	—	2026-10-21
63561016402FUROSEMIDE 20 MG TABLET	$0.0249	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain8 active DMFs14 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVFUROSEMIDE USP

DMF 25651975

FIS FABBRICA ITALIANA SINTETICI SPAFUROSEMIDE

DMF 35131979

IPCA LABORATORIES LTDFUROSEMIDE USP

DMF 101091993

EUROAPI GERMANY GMBHFUROSEMIDE (BULK)

DMF 117851995

SRI KRISHNA PHARMACEUTICALS LTDFUROSEMIDE USP

DMF 233962009

CURIA INDIA PRIVATE LIMITEDFUROSEMIDE USP

DMF 302882016

KALINTIS HEALTHCARE PVT LTDFUROSEMIDE USP

DMF 330622018

SMS LIFESCIENCES INDIA LTDFUROSEMIDE USP

DMF 399602024

HOECHST CELANESE CORPInactiveFUROSEMIDE

DMF 18341971

SOLMAG SPAInactiveFUROSEMIDE

DMF 26491976

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveFUROSEMIDE USP

DMF 30331977

CIECH POLFAInactiveFUROSEMIDE

DMF 31341978

SCHARPER SPAInactiveFUROSEMIDE

DMF 32651978

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveFUROSEMIDE USP XIX, BULK

DMF 33311978

DINAMITE DIPHARMA SPAInactiveFUROSEMIDE USP

DMF 33641978

ORION CORP FARMOS CHEMICAL PLANTInactiveFUROSEMIDE

DMF 34351979

SELOC AGInactiveFUROSEMIDE

DMF 55471984

SALSBURY CHEMICALS INCInactiveFUROSEMIDE USP

DMF 59931985

INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALEInactiveFUROSEMIDE USP

DMF 63231986

TRIFARMA SPAInactiveFUROSEMIDE

DMF 128961998

OLON SPAInactiveFUROSEMIDE

DMF 199752006

MANGALAM DRUGS AND ORGANICS LTDInactiveFUROSEMIDE USP

DMF 253182011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2026	SUPPL -71	View Letter (PDF)
Dec 23, 2020	SUPPL -66	View Letter (PDF)
Oct 12, 2016	SUPPL -63	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 1984