Viewing data from:

FEBUXOSTAT

ANDA

FEBUXOSTAT | A210461 | MSN LABORATORIES PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ULORIC(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$0.2810

per ea

Lowest NADAC/Unit

$0.2114

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72205002930FEBUXOSTAT 80 MG TABLET	$0.2810	EA	Generic	—	2026-08-19
00904748503FEBUXOSTAT 80 MG TABLET	$0.2810	EA	Generic	—	2026-08-19
00904739646FEBUXOSTAT 80 MG TABLET	$0.2810	EA	Generic	—	2026-08-19
72205002830FEBUXOSTAT 40 MG TABLET	$0.2114	EA	Generic	—	2026-08-19
00904739546FEBUXOSTAT 40 MG TABLET	$0.2114	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$143.10

Highest Price

$143.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00904-7395-46FEBUXOSTAT 40MG TAB	$143.10	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030
00904-7396-46FEBUXOSTAT 80MG TAB	$143.10	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain27 active DMFs5 inactive

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

DR REDDYS LABORATORIES LTDFEBUXOSTAT

DMF 248222011

CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTDFEBUXOSTAT

DMF 260432013

ZYDUS LIFESCIENCES LTDFEBUXOSTAT API

DMF 260712012

MSN ORGANICS PRIVATE LTDFEBUXOSTAT [ROUTE CODE FUG]

DMF 262892012

ALEMBIC PHARMACEUTICALS LTDFEBUXOSTAT

DMF 264172012

LUPIN MANUFACTURING SOLUTIONS LTDFEBUXOSTAT (MICRONIZED)

DMF 265822013

MATRIX PHARMACORP PRIVATE LTDFEBUXOSTAT

DMF 266572013

SUN PHARMACEUTICAL INDUSTRIES LTDFEBUXOSTAT

DMF 267222012

EMCURE PHARMACEUTICALS LTDFEBUXOSTAT

DMF 268152013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDFEBUXOSTAT

DMF 268482013

MACLEODS PHARMACEUTICALS LTDFEBUXOSTAT

DMF 281492014

INDOCO REMEDIES LTDFEBUXOSTAT HEMIHYDRATE (FORM G)

DMF 288342015

TAPI NL BVFEBUXOSTAT

DMF 288972015

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDFEBUXOSTAT HEMIHYDRATE

DMF 297162015

JUBILANT PHARMOVA LTDFEBUXOSTAT

DMF 303532016

MSN ORGANICS PRIVATE LTDFEBUXOSTAT

DMF 313402017

APITORIA PHARMA PRIVATE LTDFEBUXOSTAT

DMF 313972017

HEC PHARM CO LTDFEBUXOSTAT NON-STERILE BULK DRUG SUBSTANCE

DMF 318382017

WANBANG BIOPHARMACEUTICALSFEBUXOSTAT

DMF 322842017

JIANGXI SYNERGY PHARMACEUTICAL CO LTDFEBUXOSTAT

DMF 327802018

LUPIN MANUFACTURING SOLUTIONS LTDFEBUXOSTAT (PROCESS-B)

DMF 337572019

TORRENT PHARMACEUTICALS LTDFEBUXOSTAT

DMF 342082020

METROCHEM API PRIVATE LTDFEBUXOSTAT

DMF 355782021

METROCHEM API PRIVATE LTDFEBUXOSTAT FORM-A

DMF 357972021

AMI LIFESCIENCES PRIVATE LTDFEBUXOSTAT

DMF 379962023

DASAMI LAB PRIVATE LTDFEBUXOSTAT

DMF 393492024

LINHAI TIANYU PHARMACEUTICAL CO LTDFEBUXOSTAT

DMF 416232025

ALP PHARM BEIJING CO LTDInactiveFEBUXOSTAT

DMF 256642010

HETERO DRUGS LTDInactiveFEBUXOSTAT (FORM-H1)

DMF 262172012

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveFEBUXOSTAT

DMF 265492012

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFEBUXOSTAT

DMF 266072013

SIGNA SA DE CVInactiveFEBUXOSTAT

DMF 267412012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 5, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 2019

No patent or exclusivity listings for this strength.

#002 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 2019