Propafenone Hydrochloride

Product NDC
60687-709
11-digit product format
606870709
Labeler code
60687
Product ID
60687-709_3f172eeb-8316-cdbc-e063-6394a90a1e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075938
Marketing category
ANDA
Marketing start
2022-10-13
Marketing end
2027-01-31
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone Hydrochloride

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
60687-709-01Propafenone Hydrochloride100 in 1 CARTONTABLET, FILM COATED1003
60687-709-11Propafenone Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-709-01EA - Each60687-7096effeb97-b132-4da4-bb5b-0da819dc47b012022-10-06
60687-709-11EA - Each60687-709382bcd7a-87ad-4d7e-8d5c-ca8de1d7daac12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-709PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240910_343e4ad7-05e2-4e6c-8f8e-91c07739cae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSN343e4ad7-05e2-4e6c-8f8e-91c07739cae23
861424propafenone hydrochloride 150 MG Oral TabletSCD343e4ad7-05e2-4e6c-8f8e-91c07739cae23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-709-0160687070901100 BLISTER PACK in 1 CARTON (60687-709-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-709-11) 100 blister pack2022-10-132027-01-31NoNoCurrent
60687-709-11606870709111 in 1 BLISTER PACKHistorical