Basic Information
Propafenone HCl
0591-0583
Regulatory Information
0591-0583
ANDA075203
C73584
February 28, 2019
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 t ablets , for oral use Initial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
23
Company Information
119723554
Active Ingredients
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
POLYDEXTROSE
Code: VH2XOU12IE
Class Code: IACT
CROSPOVIDONE
Code: 2S7830E561
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U