FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
50090-1134
11-digit product format
500901134
Labeler code
50090
Product ID
50090-1134_f293d2ab-428b-47bb-8995-07c65f2c5ff1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075938
Marketing category
ANDA
Marketing start
2002-10-17
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
559c7edd-6d87-934f-8fcc-0cd5e9651949Product name720240226
06783798-d93a-d4be-8416-24bb30819d48Product name220160630

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1134-02023-01-30C16284748780-1f386c64a-434b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1134-0Propafenone Hydrochloride60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1134-0EA - Each50090-11345d5c2a08-c2d5-49e4-97a3-4011adcd6c9712021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1134PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210616_5b3890cc-9078-4e11-b396-a26f75da3eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861427propafenone HCl 225 MG Oral TabletPSN5b3890cc-9078-4e11-b396-a26f75da3eb27
861427propafenone hydrochloride 225 MG Oral TabletSCD5b3890cc-9078-4e11-b396-a26f75da3eb27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1134-05009011340060 TABLET, FILM COATED in 1 BOTTLE (50090-1134-0) 2014-11-280000-00-00NoNoCurrent