Naproxen Oral Suspension
These highlights do not include all the information needed to use NAPROXEN ORAL SUSPENSION safely and effectively. See full prescribing information for NAPROXEN ORAL SUSPENSION. NAPROXEN oral suspension, for oral use Initial U.S. Approval: 1976
Approved
Approval ID
252726a7-757a-4b97-b5b8-ffff4ac1d103
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-151
Application NumberANDA211910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen oral
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2022
FDA Product Classification
INGREDIENTS (13)
NAPROXENActive
Quantity: 125 mg in 5 mL
Code: 57Y76R9ATQ
Classification: ACTIB
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT