Application 019386
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | INJECTABLE; INJECTION | 250MG/ML | No | No |
| 003 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 004 | BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | Yes | Yes |
| 005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | Yes | Yes |
| 006 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
| 007 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019386-003 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | ||
| N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 |
| N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 |
| N019386-006 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 |
| N019386-007 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019386-004 | AP |
| N019386-005 | AP |
| N019386-006 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-003 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | 1988-08-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-004 | BREVIBLOC IN PLASTIC CONTAINER | 1GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2001-02-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | 2GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-01-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-006 | BREVIBLOC | 10MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2003-02-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-007 | BREVIBLOC | 20MG/ML | INJECTABLE / INJECTION | 2003-05-28 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019386-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019386-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019386-006 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019386-006 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019386-006 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019386-006 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019386-006 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-005 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019386-006 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-005 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019386-006 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-005 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019386-006 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019386-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019386-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019386-006 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019386-004 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019386-005 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019386-006 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019386-004 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019386-005 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019386-006 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019386-004 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019386-005 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019386-006 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019386-004 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019386-005 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019386-006 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019386-004 | AP | 1 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N019386-004 | 6310094 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-004 | 6528540 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-004 | 6310094*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-004 | 6528540*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-005 | 6310094 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-005 | 6528540 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-005 | 6310094*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-005 | 6528540*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-006 | 6310094 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-006 | 6528540 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-006 | 6310094*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-006 | 6528540*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-007 | 6310094 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-007 | 6528540 | 2021-01-12 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-007 | 6310094*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019386-007 | 6528540*PED | 2021-07-12 | Pediatric extension | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-004 | 6310094 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-004 | 6528540 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-004 | 6310094*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-004 | 6528540*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-005 | 6310094 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-005 | 6528540 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-005 | 6310094*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-005 | 6528540*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-006 | 6310094 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-006 | 6528540 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-006 | 6310094*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-006 | 6528540*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-007 | 6310094 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-007 | 6528540 | 2021-01-12 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-007 | 6310094*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019386-007 | 6528540*PED | 2021-07-12 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-004 | 6310094 | 2021-01-12 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-004 | 6528540 | 2021-01-12 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-004 | 6310094*PED | 2021-07-12 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-004 | 6528540*PED | 2021-07-12 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-005 | 6310094 | 2021-01-12 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-005 | 6528540 | 2021-01-12 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-005 | 6310094*PED | 2021-07-12 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019386-005 | 6528540*PED | 2021-07-12 | Pediatric extension | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| Brevibloc | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc | 38a8b23a-fca8-45f4-a09a-9c8b21f522cd | 2025-10-27 | Warnings, Adverse reactions | 019386 NDA019386 0404-9825 |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 220a07b8-5c68-41a3-8705-fd91f14c50b4 | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 10019-668 10019-672 |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 9c593cdb-cdfe-4492-8862-9b05116aa25e | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 10019-670 10019-666 |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 595cc3d5-1306-4828-aefa-5595219ffd62 | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 10019-115 10019-055 10019-075 |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 2025-01-08 | Warnings, Adverse reactions | 019386 NDA019386 51662-1427 |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Corporation | f0a56c07-8f0f-4499-8d00-f13a966bf988 | 2023-06-15 | Warnings, Adverse reactions | 019386 NDA019386 10019-120 |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bdd5315-75ce-1537-e053-2991aa0a6549 | 2023-05-22 | Warnings, Adverse reactions | 019386 NDA019386 71872-7136 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9825 | Brevibloc | esmolol hydrochloride | Henry Schein, Inc | NDA | Current |
| 0404-9825 | Brevibloc | esmolol hydrochloride | Henry Schein, Inc | NDA | Current |
| 0404-9825 | Brevibloc | Brevibloc | Henry Schein, Inc | NDA | Current |
| 0641-2965 | Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | West Ward Pharmaceutical Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-055 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-075 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-115 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-120 | Esmolol Hydrochloride | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-120 | Esmolol Hydrochloride | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-120 | Esmolol Hydrochloride | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-120 | Esmolol Hydrochloride | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-120 | Esmolol Hydrochloride | Esmolol Hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-666 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-668 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-670 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 10019-672 | BREVIBLOC | esmolol hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 51662-1427 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1427 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 52584-017 | Esmolol | Esmolol | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-115 | Brevibloc | Brevibloc | General Injectables & Vaccines | NDA | Current |
| 52584-115 | Brevibloc | Brevibloc | General Injectables & Vaccines | NDA | Current |
| 52584-115 | Brevibloc | Brevibloc | General Injectables & Vaccines | NDA | Current |
| 52584-115 | Brevibloc | Brevibloc | General Injectables & Vaccines | NDA | Current |
| 55154-2888 | Esmolol Hydrochloride | Esmolol Hydrochloride | Cardinal Health | NDA | Current |
| 71872-7136 | Esmolol Hydrochloride | Esmolol Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
| 71872-7136 | Esmolol Hydrochloride | Esmolol Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84138 | SUPPL | 2025-11-12 |
| 84137 | SUPPL | 2025-11-12 |
| 74538 | SUPPL | 2023-06-16 |
| 74506 | SUPPL | 2023-06-16 |
| 17383 | SUPPL | 2012-12-13 |
| 11498 | SUPPL | 2012-12-13 |
| 20237 | SUPPL | 2008-02-19 |
| 20236 | SUPPL | 2008-02-19 |
| 20235 | SUPPL | 2008-02-19 |
| 20234 | SUPPL | 2008-02-19 |
| 40906 | SUPPL | 2007-12-06 |
| 40905 | SUPPL | 2007-12-06 |
| 40904 | SUPPL | 2007-12-06 |
| 40903 | SUPPL | 2007-12-06 |
| 20233 | SUPPL | 2007-12-06 |
| 20232 | SUPPL | 2007-12-06 |
| 17382 | SUPPL | 2007-11-08 |
| 33734 | SUPPL | 2007-11-07 |
| 40907 | SUPPL | 2007-09-14 |
| 20239 | SUPPL | 2007-09-14 |
| 20238 | SUPPL | 2007-09-14 |
| 40909 | SUPPL | 2007-07-06 |
| 40902 | ORIG | 2004-10-04 |
| 1312 | SUPPL | 2003-08-26 |
| 40908 | SUPPL | 2003-07-08 |
| 17381 | SUPPL | 2003-05-30 |
| 1311 | SUPPL | 2003-03-10 |
| 17380 | SUPPL | 2003-01-27 |
| 1310 | SUPPL | 2003-01-27 |