Propafenone Hydrochloride

Product NDC
63629-1989
11-digit product format
636291989
Labeler code
63629
Product ID
63629-1989_1a40d563-a1f1-4a18-b7db-b6a460f0a33d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076550
Marketing category
ANDA
Marketing start
2015-03-31
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861430

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1989-1Propafenone Hydrochloride100 in 1 BOTTLETABLET, COATED100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1989-1EA - Each63629-1989ca4ccf49-9b00-45f0-a96d-8b2bd0bb0e8e12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1989PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240820_7bcc5d3b-b2c9-4753-9eef-b5360538f5ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861430propafenone HCl 300 MG Oral TabletPSN7bcc5d3b-b2c9-4753-9eef-b5360538f5ee104
861430propafenone hydrochloride 300 MG Oral TabletSCD7bcc5d3b-b2c9-4753-9eef-b5360538f5ee104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1989-163629198901100 TABLET, COATED in 1 BOTTLE (63629-1989-1) 2021-02-020000-00-00NoNoCurrent