NAPROXEN
Approved
Approval ID
c0a4839b-7154-c82c-e053-2a95a90a7e6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
QPharma Inc
DUNS: 030620888
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 Code42708-140
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (4)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB