NAPROXEN
Naproxen - 138, 139, 140
Approved
Approval ID
80217f60-9b41-911a-2bee-aa7de615c9d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2016
Manufacturers
FDA
Biomes Pharmaceuticals
DUNS: 078644310
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 Code69150-138
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2016
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NAPROXENActive
Quantity: 250 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
NAPROXEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69150-139
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2016
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
NAPROXEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69150-140
Application NumberANDA091416
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2016
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT