Oxaprozin

Basic Information

Product Name

Oxaprozin

FDA Product Code

71335-0902

Regulatory Information

NDC Product Code

71335-0902

Application Number

ANDA075845

Marketing Category

C73584

Effective Date

May 23, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use OXAPROZIN TABLETS safely and effectively. See full prescribing information for OXAPROZIN TABLETS. OXAPROZIN tablets, for oral use Initial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

METHYLCELLULOSE (100 MPA.S)

Code: 4GFU244C4J

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLACRILIN POTASSIUM

Code: 0BZ5A00FQU

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

OXAPROZIN

Quantity: 600 mg in 1 1

Code: MHJ80W9LRB

Class Code: ACTIB

Active Moieties

Code: MHJ80W9LRB

Oxaprozin

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSE, UNSPECIFIED

SILICON DIOXIDE

MAGNESIUM STEARATE

METHYLCELLULOSE (100 MPA.S)

MICROCRYSTALLINE CELLULOSE

POLACRILIN POTASSIUM

POLYETHYLENE GLYCOL, UNSPECIFIED

POLYSORBATE 80

STARCH, CORN

TITANIUM DIOXIDE

Active Moieties

OXAPROZIN