Naproxen
Naproxen Tablets USPNaproxen Sodium Tablets USP
Approved
Approval ID
4bbe6e74-b13e-4609-b4cc-aa0b00d66df8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
Products 5
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 Code63874-301
Application NumberANDA078250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NAPROXENActive
Quantity: 250 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-326
Application NumberANDA078250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (5)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-489
Application NumberANDA078314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (6)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 275 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-325
Application NumberANDA078250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (5)
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
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 Code63874-339
Application NumberANDA078314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (6)
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT