Basic Information
Propafenone Hydrochloride
0603-5448
Regulatory Information
0603-5448
ANDA075938
C73584
August 23, 2022
USA
These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
16
Company Information
092733690
Active Ingredients
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)
Code: 23ZQ42JZZH
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATE
Code: U72Q2I8C85
Class Code: IACT
POLYVINYL ALCOHOL (100000 MW)
Code: 949E52Z6MY
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U