FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
59651-278
11-digit product format
596510278
Labeler code
59651
Product ID
59651-278_ef0c975d-08ee-4649-9017-4f7f1a2981a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213096
Marketing category
ANDA
Marketing start
2023-02-21
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
425 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 HYDROCHLORIDE425 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861156, 861164, 861171

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
559c7edd-6d87-934f-8fcc-0cd5e9651949Product name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
59651-278-05Propafenone Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5002
59651-278-60Propafenone Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
59651-278-90Propafenone Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-278-60EA - Each59651-278ca0cb82e-9010-4014-8906-5132cc7618f712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-278PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, 3 package rows20250207_1c4fc726-3f5b-4b12-a66e-727c5133d1d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSN1c4fc726-3f5b-4b12-a66e-727c5133d1d92
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSN1c4fc726-3f5b-4b12-a66e-727c5133d1d92
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSN1c4fc726-3f5b-4b12-a66e-727c5133d1d92
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCD1c4fc726-3f5b-4b12-a66e-727c5133d1d92
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCD1c4fc726-3f5b-4b12-a66e-727c5133d1d92
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCD1c4fc726-3f5b-4b12-a66e-727c5133d1d92
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSY1c4fc726-3f5b-4b12-a66e-727c5133d1d92
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSY1c4fc726-3f5b-4b12-a66e-727c5133d1d92
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSY1c4fc726-3f5b-4b12-a66e-727c5133d1d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-278-0559651027805500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05) 2023-02-21NoNoCurrent
59651-278-605965102786060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60) 2023-02-21NoNoCurrent
59651-278-905965102789090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90) 2023-02-21NoNoCurrent