Naproxen Sodium
Naproxen Tablets, USPNaproxen Sodium Tablets, USP
Approved
Approval ID
577b9f26-ab59-4b15-a26a-465f0d255bad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3043
Application NumberANDA078314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2012
FDA Product Classification
INGREDIENTS (6)
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3359
Application NumberANDA078314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2012
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 275 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT