Brevibloc
- Product NDC
- 52584-115
- 11-digit product format
- 525840115
- Labeler code
- 52584
- Product ID
- 52584-115_40e3b8e6-5893-4f70-963f-9728122307cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brevibloc
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables & Vaccines
- Application
- NDA019386
- Marketing category
- NDA
- Marketing start
- 2010-07-01
- Marketing end
- 2024-01-31
- 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
- 0000-00-00
- 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 product | product | 52584-115 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 52584-115 | 52584-115-39 | D | Discontinued by firm | 2026-08-17 |
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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 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 | 52584-115-39 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Esmolol Hydrochloride | ACTIVE INGREDIENT | V05260LC8D | BREVIBLOC INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES] | 3 | |
| Esmolol | ACTIVE MOIETY | MDY902UXSR | BREVIBLOC INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES] | 3 |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52584-115-39 | 52584011539 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-115-39) > 10 mL in 1 VIAL, SINGLE-DOSE | 2016-09-14 | 0000-00-00 | No | No | Current |