FENOPROFEN CALCIUM
These highlights do not include all the information needed to use FENOPROFEN CALCIUM CAPSULES safely and effectively. See full prescribing information for FENOPROFEN CALCIUM CAPSULES. FENOPROFEN CALCIUM capsules, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
4aa38cca-9f8f-4ab6-8103-4f1f48801a43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
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 Code16571-688
Application NumberANDA214475
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOPROFEN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (11)
FENOPROFEN CALCIUMActive
Quantity: 400 mg in 1 1
Code: 0X2CW1QABJ
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT