Naproxen
These highlights do not include all the information needed to use NAPROXEN Tablets, safely and effectively. See full prescribing information for NAPROXEN Tablets. NAPROXEN tablets for oral use Initial U.S. Approval: 1976
Approved
Approval ID
0de6d673-fa76-e9c0-e063-6394a90a9ded
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82868-030
Application NumberANDA074140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (5)
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 375 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB