Application 205703
- Type
- NDA
- Sponsor
- HQ SPCLT PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2.5GM/250ML (10MG/ML) | Yes | Yes |
| 002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | |
| N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | |
| N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205703-001 | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 2.5GM/250ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205703-002 | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-04-07 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-001 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | 8829054 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205703-002 | 8835505 | 2033-03-15 | Drug product | 2016-05-18 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 1f5707f2-a8a7-4a5f-b846-64585b5e3f9f | 2026-09-10 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc | 38a8b23a-fca8-45f4-a09a-9c8b21f522cd | 2026-08-06 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | ProPharma Distribution | 3853a26d-782d-f4e7-e063-6294a90a6e47 | 2025-12-18 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | 9c1e3a64-0ef0-4071-ad6f-63ff8789b198 | 2025-06-18 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 220a07b8-5c68-41a3-8705-fd91f14c50b4 | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 9c593cdb-cdfe-4492-8862-9b05116aa25e | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 595cc3d5-1306-4828-aefa-5595219ffd62 | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Mylan Institutional LLC | 94f069f9-dd52-4a69-a103-ebdb4294f088 | 2025-02-27 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | 519cc19c-e2b6-4984-bfad-45276d4cf0e6 | 2025-01-27 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 2025-01-08 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Fresenius Kabi USA, LLC | fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2 | 2024-11-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Eugia US LLC | ac22475d-2d78-469f-9435-b403ac4ee380 | 2024-09-17 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 789730fa-eaca-4986-e053-2a91aa0a5339 | 2024-02-19 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9a52d2fd-e551-f8f1-e053-2995a90a6c09 | 2024-01-29 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| esmolol hydrochloride | ESMOLOL HYDROCHLORIDE | Sagent Pharmaceuticals | f12fb0fd-fa05-49fc-b5e3-a2050b816ef2 | 2023-07-12 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Gland Pharma Limited | 017023a9-00f0-4284-861f-a3634d4fdb17 | 2023-06-23 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Corporation | f0a56c07-8f0f-4499-8d00-f13a966bf988 | 2023-06-15 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bb9921c-a0f9-309f-e053-2a91aa0a1e5e | 2023-05-30 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bdd5315-75ce-1537-e053-2991aa0a6549 | 2023-05-22 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 993df35b-0006-4892-e053-2a95a90a0dba | 2022-12-10 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 44567-811 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |
| 44567-811 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |
| 44567-811 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |
| 44567-812 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |
| 44567-812 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |
| 44567-812 | Esmolol Hydrochloride | Esmolol Hydrochloride | WG Critical Care, LLC | NDA | Current |