ESMOLOL HYDROCHLORIDE
- Product NDC
- 51662-1427
- 11-digit product format
- 516621427
- Labeler code
- 51662
- Product ID
- 51662-1427_2b3832b9-14ba-a453-e063-6394a90a0330
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESMOLOL HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- NDA019386
- Marketing category
- NDA
- Marketing start
- 2019-12-21
- Substance
- ESMOLOL HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESMOLOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESMOLOL HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V05260LC8D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1736541 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| ab3d10ea-fe48-4811-8e72-bb51600b35f9 | Product name | 5 | 20230103 |
| 9cb9173b-3912-466b-8256-366e71d49fce | Product name | 1 | 20190402 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1427-1 | ESMOLOL HYDROCHLORIDE | 250 mL in 1 BAG | INJECTION | 250 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1427 | ESMOLOL HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250110_9a3e69ab-3ffe-33af-e053-2a95a90a6524.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 |
|---|---|---|---|---|---|---|
| Brevibloc | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc | 38a8b23a-fca8-45f4-a09a-9c8b21f522cd | 2025-10-27 | Warnings, Adverse reactions | 019386 NDA019386 |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 220a07b8-5c68-41a3-8705-fd91f14c50b4 | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 9c593cdb-cdfe-4492-8862-9b05116aa25e | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 595cc3d5-1306-4828-aefa-5595219ffd62 | 2025-03-14 | Warnings, Adverse reactions | 019386 NDA019386 |
| 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 |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bdd5315-75ce-1537-e053-2991aa0a6549 | 2023-05-22 | Warnings, Adverse reactions | 019386 NDA019386 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1736541 | esmolol HCl 2500 MG in 250 ML Injection | PSN | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 3 |
| 1736541 | 250 ML esmolol hydrochloride 10 MG/ML Injection | SCD | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 3 |
| 1736541 | esmolol HCl 2500 MG per 250 ML Injection | SY | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51662-1427-1 | 51662142701 | 250 mL in 1 BAG (51662-1427-1) | 250 ml | 2019-12-21 | 0000-00-00 | No | No | Current |