FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
69680-130
11-digit product format
696800130
Labeler code
69680
Product ID
69680-130_827a5fb5-9318-4116-9e23-6b75e469dd77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics
Application
ANDA210339
Marketing category
ANDA
Marketing start
2019-01-28
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
69680-130-60Propafenone Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE603
69680-130-92Propafenone Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-130PROPAFENONE HYDROCHLORIDE (PROPAFENONE) CAPSULE, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS]3Current NDC, Legacy NDC, 2 package rows20241228_bc1d2548-15a3-4986-92b1-c3ddfb35343a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSNbc1d2548-15a3-4986-92b1-c3ddfb35343a3
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSNbc1d2548-15a3-4986-92b1-c3ddfb35343a3
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSNbc1d2548-15a3-4986-92b1-c3ddfb35343a3
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCDbc1d2548-15a3-4986-92b1-c3ddfb35343a3
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCDbc1d2548-15a3-4986-92b1-c3ddfb35343a3
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCDbc1d2548-15a3-4986-92b1-c3ddfb35343a3
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSYbc1d2548-15a3-4986-92b1-c3ddfb35343a3
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSYbc1d2548-15a3-4986-92b1-c3ddfb35343a3
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSYbc1d2548-15a3-4986-92b1-c3ddfb35343a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69680-130-606968001306060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60) 2019-01-280000-00-00NoNoCurrent
69680-130-9269680013092500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92) 2019-01-280000-00-00NoNoCurrent