FDA.reportPublic FDA data

PROPAFENONE HYDROCHLORIDE

Product NDC
59651-256
11-digit product format
596510256
Labeler code
59651
Product ID
59651-256_b59b252f-8b73-4f72-8d01-4d2076c18fa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPAFENONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202445
Marketing category
ANDA
Marketing start
2019-10-25
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, 861427, 861430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
559c7edd-6d87-934f-8fcc-0cd5e9651949Product name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
06783798-d93a-d4be-8416-24bb30819d48Product name220160630
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-256-01PROPAFENONE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004
59651-256-33PROPAFENONE HYDROCHLORIDE300 in 1 BOTTLETABLET, FILM COATED3004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-256-01EA - Each59651-256eebc20d6-9e2b-48b6-b27b-329c23aa6a8812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-256PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20230722_0c887381-42fe-4f37-858a-d9ffb218dd1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSNfaa8e971-4b4f-43db-be97-33acc16dcdc7100
861424propafenone hydrochloride 150 MG Oral TabletSCDfaa8e971-4b4f-43db-be97-33acc16dcdc7100
861424propafenone HCl 150 MG Oral TabletPSN0c887381-42fe-4f37-858a-d9ffb218dd1c4
861427propafenone HCl 225 MG Oral TabletPSN0c887381-42fe-4f37-858a-d9ffb218dd1c4
861430propafenone HCl 300 MG Oral TabletPSN0c887381-42fe-4f37-858a-d9ffb218dd1c4
861424propafenone hydrochloride 150 MG Oral TabletSCD0c887381-42fe-4f37-858a-d9ffb218dd1c4
861427propafenone hydrochloride 225 MG Oral TabletSCD0c887381-42fe-4f37-858a-d9ffb218dd1c4
861430propafenone hydrochloride 300 MG Oral TabletSCD0c887381-42fe-4f37-858a-d9ffb218dd1c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-256-0159651025601100 TABLET, FILM COATED in 1 BOTTLE (59651-256-01) 2019-10-250000-00-00NoNoCurrent
59651-256-3359651025633300 TABLET, FILM COATED in 1 BOTTLE (59651-256-33) 2019-10-250000-00-00NoNoCurrent