Naproxen
Naproxen Tablets, USP
Approved
Approval ID
5e802e0f-8f76-499e-9448-2c9fb8cab96b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
Products 1
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 Code75921-190
Application NumberANDA075927
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 23, 2012
FDA Product Classification
INGREDIENTS (4)
NAPROXENActive
Quantity: 500 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