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Nabumetone

NABUMETONE TABLETS USP Rx Only

Approved
Approval ID

06f73fa8-7a8f-4160-939e-a25980a11906

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Nabumetone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-2292
Application NumberANDA078420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification

INGREDIENTS (7)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 11/26/2020

DESCRIPTION

structure1

Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2- butanone. It has the following structure:

Nabumetone, USP is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4.

Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, polyethylene glycol and titanium dioxide.

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Nabumetone - FDA Drug Approval Details