Propafenone Hydrochloride
- Product NDC
- 71205-940
- 11-digit product format
- 712050940
- Labeler code
- 71205
- Product ID
- 71205-940_3b289523-f57e-4424-a3ff-d82aeea7a3a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propafenone
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212928
- Marketing category
- ANDA
- Marketing start
- 2020-07-13
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 71205-940 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 71205-940 | 71205-940-60 | D | Discontinued by firm | 2026-08-03 |
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 product | product | 71205-940 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71205-940 | 71205-940-60 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212928-001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | ||
| A212928-002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | ||
| A212928-003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 |
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.
| 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 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | 2020-06-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-002 | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-003 | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212928-001 | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2020-06-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212928-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212928-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212928-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212928-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212928-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212928-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212928-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212928-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212928-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212928-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212928-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212928-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212928-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212928-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212928-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212928-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212928-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212928-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212928-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A212928-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A212928-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212928-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212928-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212928-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A212928-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A212928-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A212928-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A212928-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A212928-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A212928-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A212928-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212928-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212928-003 | AB | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212928-001 | AB | 1 | 6a51e52b5d6a… |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-940-60 | EA - Each | 71205-940 | fcc1a693-bd53-40d9-b3b8-e01656eb7493 | 1 | 2021-09-07 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71205-940-60 | 71205094060 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-940-60) | 2020-11-19 | 0000-00-00 | No | No | Current |