Rocuronium Bromide
- Product NDC
- 55579-400
- 11-digit product format
- 555790400
- Labeler code
- 55579
- Product ID
- 55579-400_8d585a1d-976f-53d3-e053-2995a90a14ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROCURONIUM BROMIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Solupharm Pharmazeutische Erzeugnisse GmbH
- Application
- ANDA091115
- Marketing category
- ANDA
- Marketing start
- 2019-07-15
- Marketing end
- 0000-00-00
- Substance
- ROCURONIUM BROMIDE
- Active strength
- 50 mg/5mL
- Pharmacologic classes
- Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091115-001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | |
| A091115-002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091115-001 | AP |
| A091115-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091115-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091115-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2012-08-27 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091115-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091115-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091115-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091115-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091115-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091115-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091115-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091115-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091115-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091115-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091115-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091115-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091115-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091115-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091115-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091115-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091115-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091115-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091115-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091115-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091115-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091115-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091115-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091115-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091115-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091115-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091115-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091115-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091115-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091115-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091115-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091115-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091115-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091115-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091115-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091115-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091115-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091115-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091115-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091115-002 | AP | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| rocuronium bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 0943a290-49e8-600f-e063-6294a90a3370 | 2023-11-03 | Warnings, Adverse reactions | 091115 ANDA091115 |
| rocuronium bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 6ba5364d-52e8-a4c0-e053-2991aa0a9e2e | 2023-05-31 | Warnings, Adverse reactions | 091115 ANDA091115 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | c8e9bdfb-1121-6f5b-e053-2a95a90a4627 | 2023-05-02 | Warnings, Adverse reactions | 091115 ANDA091115 |
| rocuronium bromide | ROCURONIUM BROMIDE | XGen Pharmaceuticals DJB, Inc. | b73f192c-2912-4ec3-9b4f-05a58d9b35ba | 2022-12-02 | Warnings, Adverse reactions | 091115 ANDA091115 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Baxter Healthcare Corporation | 31e15c3f-aefa-4379-b684-7707744fe40d | 2019-09-30 | Warnings, Adverse reactions | 091115 ANDA091115 |