Propafenone Hydrochloride

Product NDC
63629-2105
11-digit product format
636292105
Labeler code
63629
Product ID
63629-2105_ae1bf45c-2106-497f-a42a-8fcc4ce3d9ad
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
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861424

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
63629-2105-1Propafenone Hydrochloride100 in 1 BOTTLETABLET, COATED100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2105-1EA - Each63629-2105c46cb798-cd49-48d2-9b50-5843bd791b4612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2105PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20241004_9da7e6d2-64da-43cd-9575-b2b0d5d412dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSN9da7e6d2-64da-43cd-9575-b2b0d5d412dc105
861424propafenone hydrochloride 150 MG Oral TabletSCD9da7e6d2-64da-43cd-9575-b2b0d5d412dc105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2105-163629210501100 TABLET, COATED in 1 BOTTLE (63629-2105-1) 2021-01-290000-00-00NoNoCurrent