Propafenone Hydrochloride

Product NDC
42291-547
11-digit product format
422910547
Labeler code
42291
Product ID
42291-547_d221da1f-fd60-4540-8391-73d1615ccf76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA078540
Marketing category
ANDA
Marketing start
2016-01-21
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
425 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-547-602022-02-03C16284748780-1d6a99b39-51ec-a426-e053-dadaa90af4c26bddd7fc-2de9-4362-7a01-d28c1e836499
42291-547-602022-01-28C16284748780-1d6a99b39-51ec-a426-e053-dadaa90af4c26bddd7fc-2de9-4362-7a01-d28c1e836499

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-547-60EA - Each42291-5475736e290-4bf3-4926-b656-ce46c71905b912016-03-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-547-604229105476060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-547-60) 2016-01-210000-00-00NoNoCurrent