FDA.reportPublic FDA data

PROPAFENONE HYDROCHLORIDE

Product NDC
64380-164
11-digit product format
643800164
Labeler code
64380
Product ID
64380-164_3c3e948d-7eef-4a8b-8155-aef063cd1678
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPAFENONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA075938
Marketing category
ANDA
Marketing start
2022-08-01
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861424, 861427, 861430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
559c7edd-6d87-934f-8fcc-0cd5e9651949Product name720240226
06783798-d93a-d4be-8416-24bb30819d48Product name220160630

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-164-012025-03-28C16284748780-12cef2736-6963-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
64380-164-022025-03-28C16284748780-12cef2736-6963-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
64380-164-012025-01-30C16284748780-12cef2736-6963-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
64380-164-022025-01-30C16284748780-12cef2736-6963-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-164-01PROPAFENONE HYDROCHLORIDE300 in 1 BOTTLE, PLASTICTABLET, FILM COATED3006
64380-164-02PROPAFENONE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-164-01EA - Each64380-164db4d308e-518d-4458-b10c-75468ce6c97012022-08-04
64380-164-02EA - Each64380-1642d3a4c11-f05d-42ea-93d3-6ec34a79468a12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-164PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 2 package rows20250330_a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSNa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46
861427propafenone HCl 225 MG Oral TabletPSNa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46
861430propafenone HCl 300 MG Oral TabletPSNa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46
861424propafenone hydrochloride 150 MG Oral TabletSCDa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46
861427propafenone hydrochloride 225 MG Oral TabletSCDa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46
861430propafenone hydrochloride 300 MG Oral TabletSCDa96f9c6f-4c9c-4406-bca8-08bf9a4af1f46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-164-0164380016401300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-164-01) 2022-08-010000-00-00NoNoCurrent
64380-164-0264380016402100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-164-02) 2022-08-010000-00-00NoNoCurrent