Basic Information
FENOPROFEN CALCIUM
71205-828
Regulatory Information
71205-828
ANDA214475
C73584
August 1, 2023
USA
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
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
079196022
Active Ingredients
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CROSPOVIDONE, UNSPECIFIED
Code: 2S7830E561
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
Active Moieties
FENOPROFEN
Code: RA33EAC7KY