Nalfon
These highlights do not include all the information needed to use NALFON safely and effectively. See full prescribing information for NALFON. NALFON (fenoprofen calcium, USP) capsules, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
dfc2ab1e-0d75-4eff-9489-2afb51b02702
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Xspire Pharma
DUNS: 078312042
Products 2
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 Code42195-600
Application NumberNDA017604
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenoprofen calcium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
FENOPROFEN CALCIUMActive
Quantity: 200 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM
fenoprofen calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-308
Application NumberNDA017604
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenoprofen calcium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (11)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FENOPROFEN CALCIUMActive
Quantity: 400 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM