FDA.reportPublic FDA data

Propafenone HCl

Product NDC
50090-2975
11-digit product format
500902975
Labeler code
50090
Product ID
50090-2975_6ca2c0b6-d6cd-4e36-9a75-a58d41390cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075203
Marketing category
ANDA
Marketing start
2000-10-24
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-2975-02023-01-30C16284748780-1f386c64a-36c6-0266-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 t ablets , for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2975-0Propafenone HCl60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2975-0EA - Each50090-2975c0e17fc5-ae7c-4e05-bf78-d5ccb70c347612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2975PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20191010_a8b85cbc-dab7-49b3-b74f-6800d3f9d9f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861427propafenone HCl 225 MG Oral TabletPSNa8b85cbc-dab7-49b3-b74f-6800d3f9d9f25
861427propafenone hydrochloride 225 MG Oral TabletSCDa8b85cbc-dab7-49b3-b74f-6800d3f9d9f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2975-05009029750060 TABLET, FILM COATED in 1 BOTTLE (50090-2975-0) 2017-04-180000-00-00NoNoCurrent