MedPath
FDA Product

Propafenone Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Propafenone Hydrochloride

62559-232

Regulatory Information

62559-232

ANDA076550

C73584

January 1, 2015

USA

These highlights do not include all the information needed to use 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

3

Company Information

145588013

Active Ingredients

PROPAFENONE HYDROCHLORIDE

Quantity: 300 mg in 1 1

Code: 33XCH0HOCD

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

PROPAFENONE

Code: 68IQX3T69U

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