FDA.reportPublic FDA data

PROPAFENONE HYDROCHLORIDE

Product NDC
16571-737
11-digit product format
165710737
Labeler code
16571
Product ID
16571-737_36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPAFENONE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA205956
Marketing category
ANDA
Marketing start
2020-12-16
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
325 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 HYDROCHLORIDE325 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
16571-737-06PROPAFENONE HYDROCHLORIDE60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
16571-737-50PROPAFENONE HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-737-06EA - Each16571-7371dd13ed3-c904-4176-b435-7e5990d6902c12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-737PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 2 package rows20210527_36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSN36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSN36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSN36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCD36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCD36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCD36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSY36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSY36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSY36cf4555-6fe9-42d8-8d3b-3ca9c134a5b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-737-061657107370660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-737-06) 2020-12-160000-00-00NoNoCurrent
16571-737-5016571073750500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-737-50) 2020-12-160000-00-00NoNoCurrent