Naproxen
Naproxen Tablets USPNaproxen Sodium Tablets USP
Approved
Approval ID
a671b0fb-6b6b-43e7-994b-5de54582c4a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
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 Code42549-592
Application NumberANDA078250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2012
FDA Product Classification
INGREDIENTS (5)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-566
Application NumberANDA078314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2012
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT