PROPAFENONE HYDROCHLORIDE

Product NDC
53489-553
11-digit product format
534890553
Labeler code
53489
Product ID
53489-553_90501597-9f9b-483d-a46b-7e60c7b45cad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075998
Marketing category
ANDA
Marketing start
2001-11-29
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-553-01EA - Each53489-553db5064c4-5fd1-4666-b7e0-a7d79b06c11512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-553-0153489055301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-01) 2001-11-290000-00-00NoNoCurrent
53489-553-0353489055303250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-03) 2001-11-290000-00-00NoNoCurrent
53489-553-0553489055305500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-05) 2001-11-290000-00-00NoNoCurrent
53489-553-075348905530730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-07) 2001-11-290000-00-00NoNoCurrent
53489-553-10534890553101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-10) 2001-11-290000-00-00NoNoCurrent