FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
0832-0741
11-digit product format
008320741
Labeler code
0832
Product ID
0832-0741_45afbac0-5c1a-ebc5-e063-6294a90a4d5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA212744
Marketing category
ANDA
Marketing start
2020-06-25
Marketing end
2026-11-30
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
325 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone Hydrochloride

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
0832-0741-60Propafenone Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0741-60EA - Each0832-07417019e8f2-f592-4bc7-98b1-64903943177a12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0741PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]4Current NDC, Legacy NDC, 1 package rows20240324_8aa6f58a-2980-4caa-9c54-d55d69d5d132.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSN8aa6f58a-2980-4caa-9c54-d55d69d5d1326
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSN8aa6f58a-2980-4caa-9c54-d55d69d5d1326
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSN8aa6f58a-2980-4caa-9c54-d55d69d5d1326
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCD8aa6f58a-2980-4caa-9c54-d55d69d5d1326
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCD8aa6f58a-2980-4caa-9c54-d55d69d5d1326
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCD8aa6f58a-2980-4caa-9c54-d55d69d5d1326
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSY8aa6f58a-2980-4caa-9c54-d55d69d5d1326
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSY8aa6f58a-2980-4caa-9c54-d55d69d5d1326
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSY8aa6f58a-2980-4caa-9c54-d55d69d5d1326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-0741-600083207416060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0741-60) 2020-06-252026-10-31NoNoCurrent