Daypro

Basic Information

Product Name

Daypro

FDA Product Code

0025-1381

Regulatory Information

NDC Product Code

0025-1381

Application Number

NDA018841

Marketing Category

C73594

Effective Date

November 17, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use DAYPRO safely and effectively. See full prescribing information for DAYPRO. DAYPRO (oxaprozin) caplets, for oral useInitial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

OXAPROZIN

Quantity: 600 mg in 1 1

Code: MHJ80W9LRB

Class Code: ACTIB

METHYLCELLULOSE (100 MPA.S)

Code: 4GFU244C4J

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLACRILIN POTASSIUM

Code: 0BZ5A00FQU

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

OXAPROZIN

Code: MHJ80W9LRB

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

METHYLCELLULOSE (100 MPA.S)

MAGNESIUM STEARATE

HYPROMELLOSE, UNSPECIFIED

POLACRILIN POTASSIUM

POLYETHYLENE GLYCOL, UNSPECIFIED

TITANIUM DIOXIDE

Active Moieties

OXAPROZIN