Propafenone Hydrochloride

Product NDC
24979-086
11-digit product format
249790086
Labeler code
24979
Product ID
24979-086_87369446-d972-4cfd-9fdd-60f28753ffd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
TWi Pharmaceuticals, Inc.
Application
ANDA212928
Marketing category
ANDA
Marketing start
2020-07-13
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
325 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24979-086DDiscontinued by firm2026-08-03
excluded packagepackage24979-08624979-086-04DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct24979-086DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24979-08624979-086-04DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct24979-086DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24979-08624979-086-04DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct24979-086DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24979-08624979-086-04DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212928-001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18
A212928-002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18
A212928-003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212928-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212928-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212928-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212928-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212928-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212928-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212928-003AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212928-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212928-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212928-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212928-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212928-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212928-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212928-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212928-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212928-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212928-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212928-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212928-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212928-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212928-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212928-003AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212928-001AB16a51e52b5d6a…

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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-086-04EA - Each24979-086ea20ca83-ee80-4667-98c7-a18e37b540f912020-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-086-042497900860460 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-086-04) 2020-07-130000-00-00NoNoCurrent