Naprosyn
These highlights do not include all the information needed to use NAPROSYN SUSPENSION safely and effectively. See full prescribing information for NAPROSYN SUSPENSION. NAPROSYN (naproxen) suspension, for oral use Initial U.S. Approval: 1976
Approved
Approval ID
f9b4173d-7836-4d7d-b149-1d96f9377ad0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Athena Bioscience, LLC
DUNS: 080710928
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 Code71511-701
Application NumberNDA018965
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2018
FDA Product Classification
INGREDIENTS (11)
NAPROXENActive
Quantity: 125 mg in 5 mL
Code: 57Y76R9ATQ
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT