Daypro
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
Approved
Approval ID
ea1de47e-3101-4414-817c-0a098af8988c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxaprozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0025-1381
Application NumberNDA018841
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB
METHYLCELLULOSE (100 MPA.S)Inactive
Code: 4GFU244C4J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT