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, for oral use Initial U.S. Approval: 1976
Approved
Approval ID
53865075-2d8d-4390-b392-5645cfd90e7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0472
Application NumberANDA075927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0478
Application NumberANDA075927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0468
Application NumberANDA075927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 250 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT