Propafenone Hydrochloride

Product NDC
63629-9280
11-digit product format
636299280
Labeler code
63629
Product ID
63629-9280_f59212a8-277a-43ed-b78a-fbe1177f5a51
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
63629-9280-1Propafenone Hydrochloride100 in 1 BOTTLETABLET, COATED100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9280-1EA - Each63629-92809e3b5256-7172-453c-878e-388ce54e5f2f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9280PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20240114_a6ac2a70-e0ec-4fcd-8732-5f1637be1e60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861430propafenone HCl 300 MG Oral TabletPSNa6ac2a70-e0ec-4fcd-8732-5f1637be1e60102
861430propafenone hydrochloride 300 MG Oral TabletSCDa6ac2a70-e0ec-4fcd-8732-5f1637be1e60102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9280-163629928001100 TABLET, COATED in 1 BOTTLE (63629-9280-1) 2022-06-060000-00-00NoNoCurrent