Naproxen
NAPROXEN Tablets, USP
Approved
Approval ID
6893f59b-d572-bcbb-e053-2991aa0a864a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2018
Manufacturers
FDA
MAS MANAGEMENT GROUP, INC.
DUNS: 079363782
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 Code69677-171
Application NumberANDA078250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (7)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT