Propafenone HCl
- Product NDC
- 0591-0583
- Requested package NDC
- 0591-0583-01
- 11-digit product format
- 005910583
- Labeler code
- 0591
- Product ID
- 0591-0583_71d5cee6-245f-4d4a-8a59-e555c3ca4573
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propafenone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075203
- Marketing category
- ANDA
- Marketing start
- 2000-10-24
- 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#
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0591-0583 | 0591-0583-01 | D | Discontinued by firm | 2026-08-10 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0591-0583 | 0591-0583-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0591-0583 | 0591-0583-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075203-001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | |
| A075203-002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075203-001 | AB |
| A075203-002 | AB |
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 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075203-001 | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2000-10-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075203-002 | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET / ORAL | AB | 2000-10-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075203-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075203-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075203-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075203-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075203-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075203-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075203-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075203-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075203-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075203-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075203-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075203-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075203-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075203-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075203-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075203-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075203-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075203-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075203-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075203-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075203-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075203-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075203-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075203-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075203-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075203-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075203-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075203-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075203-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075203-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075203-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075203-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075203-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075203-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075203-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075203-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075203-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075203-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075203-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075203-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 559c7edd-6d87-934f-8fcc-0cd5e9651949 | Product name | 7 | 20240226 |
| 06783798-d93a-d4be-8416-24bb30819d48 | Product name | 2 | 20160630 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0583-01 | Propafenone HCl | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0583-01 | EA - Each | 0591-0583 | 6f17239d-d430-4dbb-aa1f-5ad3c82a0fd2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861424 | propafenone HCl 150 MG Oral Tablet | PSN | a313c111-e539-47bc-9d57-c3767f74bcca | 24 |
| 861427 | propafenone HCl 225 MG Oral Tablet | PSN | a313c111-e539-47bc-9d57-c3767f74bcca | 24 |
| 861424 | propafenone hydrochloride 150 MG Oral Tablet | SCD | a313c111-e539-47bc-9d57-c3767f74bcca | 24 |
| 861427 | propafenone hydrochloride 225 MG Oral Tablet | SCD | a313c111-e539-47bc-9d57-c3767f74bcca | 24 |
| 861427 | propafenone HCl 225 MG Oral Tablet | PSN | a8b85cbc-dab7-49b3-b74f-6800d3f9d9f2 | 5 |
| 861427 | propafenone hydrochloride 225 MG Oral Tablet | SCD | a8b85cbc-dab7-49b3-b74f-6800d3f9d9f2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0591-0583-01 | 00591058301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0583-01) | 2000-10-24 | 0000-00-00 | No | No | Current |