Naproxen
Approved
Approval ID
635f8a00-0048-4421-9f5f-f8e38034f230
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4051
Application NumberANDA075390
Product Classification
M
Marketing Category
C73584
G
Generic Name
naproxen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2011
FDA Product Classification
INGREDIENTS (9)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT