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, USP for oral use Initial U.S. Approval: 1976 excerpts Naproxen Tablets, USP 250 mg, 375 mg and 500 mg
Approved
Approval ID
1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2021
Manufacturers
FDA
MARKSANS PHARMA LIMITED
DUNS: 925822975
Products 3
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 Code25000-140
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 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
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-139
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2021
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-138
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2021
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 250 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT