Sotalol Hydrochloride
- Product NDC
- 63187-426
- Requested package NDC
- 63187-426-30
- 11-digit product format
- 631870426
- Labeler code
- 63187
- Product ID
- 63187-426_32166c61-51dc-436c-8d05-08265dc33276
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2003-11-07
- Marketing end
- 0000-00-00
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
- 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 | 63187-426 | 63187-426-30 | D | Discontinued by firm | 2026-08-11 |
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 | 63187-426 | 63187-426-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-426 | 63187-426-30 | 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 |
|---|---|---|---|---|---|---|---|
| A075563-001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-004 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075563-001 | AB |
| A075563-002 | AB |
| A075563-003 | AB |
| A075563-004 | 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 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 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 | A075563-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-004 | AB | 1 | d06236e962d9… |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | ACTIVE INGREDIENT | HEC37C70XX | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| SOTALOL | ACTIVE MOIETY | A6D97U294I | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 |
DailyMed Dashboard NDC Coverage#
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 | Bryant Ranch Prepack | 9a36d95c-6e93-4e57-befe-b5274f359244 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 667fc1f2-6ccf-4373-89d8-6a064ee7509e | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | 10b7b81d-9ce7-4025-8559-fdfa41c8b146 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | A-S Medication Solutions | bbeaba9f-0513-4980-bc29-7f9259a53ecc | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | d6c8f659-1c32-4431-bdb2-3211a1c81006 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e6ea445d-4d7c-4c32-83a7-e7683a56075b | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | b534c632-3b67-4812-a045-3e582eda6de4 | 2025-02-02 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0fd4afc7-dbf8-46be-9657-aa83bbb2c026 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 89b33c45-ece8-496f-9c3a-94ebabf73b1b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 6be8c8f2-3977-4b7f-ad45-38b3254afdab | 2024-02-07 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | f8d0daf3-5eab-44f1-9dec-40e5d9c2bbcf | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | c8ac6351-b1e9-4dd2-82f2-5980814fda15 | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 253da1e1-022a-4175-bd7f-e7673cba0767 | 2022-02-22 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-426-30 | 63187042630 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-426-30) | 30 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |