FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
70771-1527
11-digit product format
707711527
Labeler code
70771
Product ID
70771-1527_e7389f3e-074b-44ca-b767-5520390265e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA214184
Marketing category
ANDA
Marketing start
2022-02-02
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
425 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 HYDROCHLORIDE425 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
70771-1527-5Propafenone Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5002
70771-1527-6Propafenone Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1527PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20231212_b41ec863-5734-41a3-9837-6c0a962ec6eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861156propafenone HCl 225 MG 12HR Extended Release Oral CapsulePSNb41ec863-5734-41a3-9837-6c0a962ec6eb2
861164propafenone HCl 325 MG 12HR Extended Release Oral CapsulePSNb41ec863-5734-41a3-9837-6c0a962ec6eb2
861171propafenone HCl 425 MG 12HR Extended Release Oral CapsulePSNb41ec863-5734-41a3-9837-6c0a962ec6eb2
86115612 HR propafenone hydrochloride 225 MG Extended Release Oral CapsuleSCDb41ec863-5734-41a3-9837-6c0a962ec6eb2
86116412 HR propafenone hydrochloride 325 MG Extended Release Oral CapsuleSCDb41ec863-5734-41a3-9837-6c0a962ec6eb2
86117112 HR propafenone hydrochloride 425 MG Extended Release Oral CapsuleSCDb41ec863-5734-41a3-9837-6c0a962ec6eb2
861156propafenone hydrochloride 225 MG 12 HR Extended Release Oral CapsuleSYb41ec863-5734-41a3-9837-6c0a962ec6eb2
861164propafenone hydrochloride 325 MG 12 HR Extended Release Oral CapsuleSYb41ec863-5734-41a3-9837-6c0a962ec6eb2
861171propafenone hydrochloride 425 MG 12 HR Extended Release Oral CapsuleSYb41ec863-5734-41a3-9837-6c0a962ec6eb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1527-570771152705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1527-5) 2022-02-020000-00-00NoNoCurrent
70771-1527-67077115270660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1527-6) 2022-02-020000-00-00NoNoCurrent