FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
64380-185
11-digit product format
643800185
Labeler code
64380
Product ID
64380-185_115db966-fda6-47dc-a699-e8a1180385d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA078540
Marketing category
ANDA
Marketing start
2022-04-04
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD

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
64380-185-01Propafenone Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE604
64380-185-02Propafenone Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE904
64380-185-03Propafenone Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1004
64380-185-04Propafenone Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE5004
64380-185-05Propafenone Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-185-01EA - Each64380-18571e2e953-4af3-4adb-8d6a-4e7acb9fcde812022-04-06
64380-185-02EA - Each64380-185e4ad7500-2885-47d6-8fc9-0d674b3059e612022-04-06
64380-185-04EA - Each64380-185941548c9-b8ff-43b3-9a1b-3c19ae0741e012022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-185PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 5 package rows20240528_3fc0800c-c063-48f8-ab4e-9aa9a4c3841f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-185-016438001850160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-01) 2022-04-040000-00-00NoNoCurrent
64380-185-026438001850290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-02) 2022-04-040000-00-00NoNoCurrent
64380-185-0364380018503100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-03) 2026-05-23NoNoHistorical
64380-185-0464380018504500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-04) 2022-09-300000-00-00NoNoCurrent
64380-185-05643800185051000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-05) 2026-05-23NoNoHistorical