PROPAFENONE HYDROCHLORIDE

Product NDC
53489-551
Requested package NDC
53489-551-10
11-digit product format
534890551
Labeler code
53489
Product ID
53489-551_90501597-9f9b-483d-a46b-7e60c7b45cad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075998
Marketing category
ANDA
Marketing start
2001-11-29
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53489-55153489-551-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075998-001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29
A075998-002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29
A075998-003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-2984e616aacf4f…
2026-08-18 06:07:402026-07A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORAL2001-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075998-002PROPAFENONE HYDROCHLORIDE225MGTABLET / ORAL2001-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075998-003PROPAFENONE HYDROCHLORIDE300MGTABLET / ORAL2001-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075998-001PROPAFENONE HYDROCHLORIDE150MGTABLET / ORALAB2001-11-29301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075998-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075998-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075998-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075998-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075998-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075998-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075998-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075998-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075998-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075998-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075998-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075998-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075998-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075998-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075998-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075998-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075998-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075998-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075998-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075998-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075998-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075998-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075998-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075998-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075998-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075998-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075998-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075998-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075998-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075998-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075998-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075998-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075998-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075998-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075998-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075998-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075998-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075998-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075998-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075998-001AB13f01610625f2…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-551-01EA - Each53489-551db86ad0c-b068-444a-a930-54232f55b19a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
propafenone hydrochlorideACTIVE INGREDIENT33XCH0HOCDPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
propafenoneACTIVE MOIETY68IQX3T69UPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
Carnauba waxINACTIVE INGREDIENTR12CBM0EIZPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
polydextroseINACTIVE INGREDIENTVH2XOU12IEPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1APROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
triacetinINACTIVE INGREDIENTXHX3C3X673PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.]3
PROPAFENONE HYDROCHLORIDEACTIVE INGREDIENT33XCH0HOCDPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
PROPAFENONEACTIVE MOIETY68IQX3T69UPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSNa7c8f090-c48c-44f7-9973-2cf4b491e35c2
861427propafenone HCl 225 MG Oral TabletPSNa7c8f090-c48c-44f7-9973-2cf4b491e35c2
861424propafenone hydrochloride 150 MG Oral TabletSCDa7c8f090-c48c-44f7-9973-2cf4b491e35c2
861427propafenone hydrochloride 225 MG Oral TabletSCDa7c8f090-c48c-44f7-9973-2cf4b491e35c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-551-10534890551101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-10) 2001-11-290000-00-00NoNoCurrent