FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
50090-4227
11-digit product format
500904227
Labeler code
50090
Product ID
50090-4227_cc6a2b31-5172-408b-80ce-bf65552e4e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076550
Marketing category
ANDA
Marketing start
2015-03-31
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861427

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
50090-4227-02023-02-07C16284748780-1f386c649-d353-0266-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
50090-4227-02023-01-30C16284748780-1f386c649-d353-0266-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
50090-4227-0Propafenone Hydrochloride60 in 1 BOTTLETABLET, COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4227-0EA - Each50090-42277e30c9e2-bed8-47a0-9274-ce54da63982512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4227PROPAFENONE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20240131_41b4e503-60a6-4662-a6f9-46ecf93d930a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861427propafenone HCl 225 MG Oral TabletPSN41b4e503-60a6-4662-a6f9-46ecf93d930a6
861427propafenone hydrochloride 225 MG Oral TabletSCD41b4e503-60a6-4662-a6f9-46ecf93d930a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4227-05009042270060 TABLET, COATED in 1 BOTTLE (50090-4227-0) 2019-03-270000-00-00NoNoCurrent