Propafenone Hydrochloride

Product NDC
63629-1988
11-digit product format
636291988
Labeler code
63629
Product ID
63629-1988_ff1cd958-1b7d-422c-bdfd-0fad7d98d6bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076550
Marketing category
ANDA
Marketing start
2015-03-31
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
63629-1988_ff1cd958-1b7d-422c-bdfd-0fad7d98d6bc
SPL ID
ff1cd958-1b7d-422c-bdfd-0fad7d98d6bc
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Propafenone Hydrochloride
Generic name
Propafenone Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Marketing start
2015-03-31
Marketing category
ANDA
Application number
ANDA076550
Pharmacologic classes
Antiarrhythmic [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii33XCH0HOCD
Rxcui861427
Spl Set Id2492317c-8b04-477e-a5d2-53e791fface9
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
63629-1988-1100 TABLET, COATED in 1 BOTTLE (63629-1988-1)2021-02-02No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
33XCH0HOCDPROPAFENONE HYDROCHLORIDE34183-22-7PROPAFENONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-1988-163629198801100 TABLET, COATED in 1 BOTTLE (63629-1988-1) 2021-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Propafenone HydrochlorideBryant Ranch Prepack2023-11-13HUMAN PRESCRIPTION DRUG LABEL104