FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
68382-522
11-digit product format
683820522
Labeler code
68382
Product ID
68382-522_a56d3284-65f2-4d77-bd0b-98afb084d7aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA214184
Marketing category
ANDA
Marketing start
2022-02-02
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 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 HYDROCHLORIDE225 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
06783798-d93a-d4be-8416-24bb30819d48Product name220160630

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-522-05Propafenone Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
68382-522-14Propafenone Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-522PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, Legacy NDC, 2 package rows20240324_163564b6-a8bf-4258-8ef9-19e33fb2d7bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSN163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSN163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSN163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCD163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCD163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCD163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSY163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSY163564b6-a8bf-4258-8ef9-19e33fb2d7bc3
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSY163564b6-a8bf-4258-8ef9-19e33fb2d7bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-522-0568382052205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-05) 2022-02-020000-00-00NoNoCurrent
68382-522-146838205221460 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-14) 2022-02-020000-00-00NoNoCurrent