NALFON
NALFON (fenoprofen calcium tablets, USP)
Approved
Approval ID
f6f4b654-082a-45ba-9924-41ee9667297a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Xspire Pharma, LLC
DUNS: 078312042
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenoprofen Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-688
Application NumberANDA072267
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenoprofen Calcium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FENOPROFEN CALCIUMActive
Quantity: 600 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM