NAPROXEN
Approved
Approval ID
5487dee2-5c37-4348-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4006
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2021
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