Sotalol Hydrochloride
- Product NDC
- 60505-0081
- 11-digit product format
- 605050081
- Labeler code
- 60505
- Product ID
- 60505-0081_7e1fd07e-45aa-ef32-da1b-c81f6961f216
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA076140
- Marketing category
- ANDA
- Marketing start
- 2003-02-01
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 60505-0081 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 60505-0081 | 60505-0081-0 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 60505-0081 | 60505-0081-1 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-0081-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-0081-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-0081-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-0081-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-0081-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-0081-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-0081-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-0081-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-0081-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-0081-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-0081-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-0081-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-0081-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-0081-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60505-0081-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60505-0081-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 60505-0081-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 60505-0081-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 60505-0081-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 60505-0081-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60505-0081-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60505-0081-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60505-0081-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60505-0081-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076140-001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-004 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076140-001 | AB |
| A076140-002 | AB |
| A076140-003 | AB |
| A076140-004 | 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 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076140-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SOTALOL HYDROCHLORIDE | 160 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| HEC37C70XX | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1a56c82e-7ecd-43b0-2899-f89e47adf7db | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83083289-08f8-450a-8eff-9d912bdd64bb | Product name | 1 | 20200505 |
| 8b3790df-333b-074c-6570-5beaa3352b77 | Product name | 2 | 20190213 |
| 424d69b0-0855-4fff-846d-7ced5f554385 | Product name | 1 | 20150403 |
| 9ab69b37-6a2f-6dca-a9fd-3131946f16f2 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-0081-0 | Sotalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 17 | |
| 60505-0081-1 | Sotalol Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0081-0 | EA - Each | 60505-0081 | e16d06f6-6ae9-4edc-a4e8-022bfd98eb50 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | ACTIVE INGREDIENT | HEC37C70XX | SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] | 8 | |
| SOTALOL | ACTIVE MOIETY | A6D97U294I | SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] | 8 | |
| SOTALOL HYDROCHLORIDE | ACTIVE INGREDIENT | HEC37C70XX | SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| SOTALOL | ACTIVE MOIETY | A6D97U294I | SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-0081 | SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241003_1a56c82e-7ecd-43b0-2899-f89e47adf7db.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | American Health Packaging | 4614480b-b36e-4dbd-9fc0-d083890d297d | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | AvPAK | bcbc1624-283e-732f-e053-2995a90a8f11 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Northwind Health Company, LLC | fe82c866-03d4-e07b-e053-6394a90a8b1e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Major Pharmaceuticals | 866e5717-3de2-4f19-b7c7-2275caeef78b | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Cardinal Health 107, LLC | 4f5902e1-9f9f-4c6b-817d-2efbb5e28061 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | bc35a3e8-681c-4fe8-96cd-b2a62f024c4b | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 27c73b70-99e8-40e8-8aa9-36d3addd3bb4 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 876214ba-59c4-4acc-a8ad-c6bc91837de8 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 6674d53a-7137-4822-8841-4982f702a1b8 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Apotex Corp. | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 60505-0081 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1f2ee505-eb90-885d-e063-6394a90a46a1 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | A-S Medication Solutions | 7cb4879f-31e7-4862-bc0c-d439e592d81c | 2023-12-09 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5e005309-4eca-4536-8743-c6ed9e5b3195 | 2023-08-08 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | 517824b1-11be-40a9-9066-d1a6a32a2938 | 2023-07-01 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1923422 | sotalol HCl 120 MG Oral Tablet | PSN | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923422 | sotalol HCl 120 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1923424 | sotalol HCl 160 MG Oral Tablet | PSN | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923424 | sotalol HCl 160 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 904589 | sotalol HCl 240 MG Oral Tablet | PSN | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 904589 | sotalol HCl 240 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1923426 | sotalol HCl 80 MG Oral Tablet | PSN | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923426 | sotalol HCl 80 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922720 | sotalol HCl AF 120 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | PSN | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922720 | Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922763 | Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922765 | Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1923422 | sotalol hydrochloride 120 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1923422 | sotalol hydrochloride 120 MG Oral Tablet | SCD | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923424 | sotalol hydrochloride 160 MG Oral Tablet | SCD | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923424 | sotalol hydrochloride 160 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 904589 | sotalol hydrochloride 240 MG Oral Tablet | SCD | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 904589 | sotalol hydrochloride 240 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1923426 | sotalol hydrochloride 80 MG Oral Tablet | SCD | 6674d53a-7137-4822-8841-4982f702a1b8 | 17 |
| 1923426 | sotalol hydrochloride 80 MG Oral Tablet | SCD | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | SY | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | SY | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
| 1922720 | sotalol hydrochloride AF 120 MG Oral Tablet | SY | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60505-0081-0 | 60505008100 | 100 TABLET in 1 BOTTLE (60505-0081-0) | 100 tablet | 2003-02-01 | 0000-00-00 | No | No | Current |
| 60505-0081-1 | 60505008101 | 1000 TABLET in 1 BOTTLE (60505-0081-1) | 1000 tablet | 2003-02-01 | 0000-00-00 | No | No | Current |