Propafenone Hydrochloride
- Product NDC
- 0378-1258
- Requested package NDC
- 0378-1258-91
- 11-digit product format
- 003781258
- Labeler code
- 0378
- Product ID
- 0378-1258_173fd954-8e93-4c80-b41d-60f12b19f275
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propafenone
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203803
- Marketing category
- ANDA
- Marketing start
- 2016-05-23
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 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#
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | 2026-08-03 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0378-1258 | 0378-1258-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203803-001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | ||
| A203803-002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | ||
| A203803-003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203803-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203803-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203803-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-04-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A203803-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203803-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203803-003 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203803-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203803-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203803-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203803-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A203803-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A203803-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203803-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A203803-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A203803-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203803-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A203803-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A203803-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203803-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A203803-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A203803-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203803-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203803-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203803-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203803-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203803-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203803-003 | AB | 1 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-1258-05 | EA - Each | 0378-1258 | 3d5f79c6-a328-4efc-84a6-bc379981995e | 1 | 2016-06-14 |
| 0378-1258-91 | EA - Each | 0378-1258 | c6220480-2785-4d08-a362-ae5867c58179 | 1 | 2016-06-14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-1258-91 | 00378125891 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-91) | 2016-05-23 | 0000-00-00 | No | No | Current |