Propafenone Hydrochloride

Product NDC
70771-1526
11-digit product format
707711526
Labeler code
70771
Product ID
70771-1526_e7389f3e-074b-44ca-b767-5520390265e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA214184
Marketing category
ANDA
Marketing start
2022-02-02
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
325 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1526-570771152605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1526-5) 2022-02-02NoNoHistorical
70771-1526-67077115260660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1526-6) 2022-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Propafenone HydrochlorideZydus Lifesciences Limited2023-12-11HUMAN PRESCRIPTION DRUG LABEL2