NAPROXEN
Approved
Approval ID
65944dbd-d443-76d3-e053-2a91aa0ae69f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2023
Manufacturers
FDA
H.J. Harkins Company., Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NAPROXEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-193
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT