Fenoprofen Calcium
These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
d33ad329-1ca6-ac2e-e053-2995a90a15c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2022
Manufacturers
FDA
Misemer Pharmaceuticals, Inc.
DUNS: 784121365
Products 3
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 Code0276-0503
Application NumberNDA017604
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenoprofen Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FENOPROFEN CALCIUMActive
Quantity: 400 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM
Fenoprofen Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0276-0501
Application NumberNDA017604
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenoprofen Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
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 Code0276-0502
Application NumberNDA017604
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenoprofen Calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
FENOPROFEN CALCIUMActive
Quantity: 300 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT