MedPath
FDA Product

Nabumetone

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

Basic Information

Nabumetone

63187-484

Regulatory Information

63187-484

ANDA078671

C73584

January 1, 2021

USA

Nabumetone Tablets USP

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

Proficient Rx LP

079196022

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 200

Code: R95B8J264J

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

NABUMETONE

Quantity: 500 mg in 1 1

Code: LW0TIW155Z

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

NABUMETONE

Code: LW0TIW155Z

© Copyright 2025. All Rights Reserved by MedPath