Oxaprozin
These highlights do not include all the information needed to use OXAPROZIN CAPSULES safely and effectively. See full prescribing information for OXAPROZIN CAPSULES. OXAPROZIN CAPSULES, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
75482b79-38b0-4765-af3e-726b7ad38b90
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2023
Manufacturers
FDA
Ayurax, LLC
DUNS: 117147643
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 Code73308-403
Application NumberNDA217927
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxaprozin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (7)
OXAPROZINActive
Quantity: 300 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT