Propafenone Hydrochloride

Product NDC
0591-2285
11-digit product format
005912285
Labeler code
0591
Product ID
0591-2285_06e9ec6f-973a-4ec0-a08a-de7e3432409d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202688
Marketing category
ANDA
Marketing start
2015-10-15
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 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#

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0591-2285UNFINISHEDActive or certified unfinished drug listing2026-08-10
unfinished packagepackage0591-22850591-2285-00UNFINISHEDActive or certified unfinished drug listing2026-08-10
excluded productproduct0591-2285DDiscontinued by firm2026-08-10
excluded packagepackage0591-22850591-2285-60DDiscontinued by firm2026-08-10

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip1d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipe30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipe30019b0c005…a3f0b14938b7…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipbbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf268b84574a6…26285f5ac5df…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip68b1e3bced9e…98a755eb8bc6…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-2285-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage0591-2285-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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
A202688-001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24
A202688-002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24
A202688-003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202688-001AB
A202688-002AB
A202688-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202688-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202688-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202688-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202688-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202688-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202688-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202688-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202688-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202688-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202688-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202688-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202688-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202688-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202688-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202688-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202688-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202688-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202688-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202688-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202688-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202688-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2285-60EA - Each0591-228574c74fd8-38f3-41a9-96af-3db13d76cd0f12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPAFENONE HYDROCHLORIDEACTIVE INGREDIENT33XCH0HOCDPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
PROPAFENONEACTIVE MOIETY68IQX3T69UPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
GELATININACTIVE INGREDIENT2G86QN327LPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
SHELLACINACTIVE INGREDIENT46N107B71OPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TALCINACTIVE INGREDIENT7SEV7J4R1UPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2285-000059122850015065 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0591-2285-00)22-SEP-15Current
0591-2285-600059122856060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2285-60) 2015-10-150000-00-00NoNoCurrent