propafenone hydrochloride

Product NDC
16714-825
11-digit product format
167140825
Labeler code
16714
Product ID
16714-825_59aaf0aa-9074-4563-93ba-1c97e76352a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA205268
Marketing category
ANDA
Marketing start
2017-03-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

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
16714-825-01propafenone hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-825-01EA - Each16714-8255fa05111-a537-4632-9428-04c1fbef5d1912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-825PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 1 package rows20231011_2ecd6452-ccc3-493f-9a4a-69f0fbf67a42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSN2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSN2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSN2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCD2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCD2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCD2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSY2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSY2ecd6452-ccc3-493f-9a4a-69f0fbf67a424
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSY2ecd6452-ccc3-493f-9a4a-69f0fbf67a424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-825-011671408250160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-825-01) 2018-07-160000-00-00NoNoCurrent