ROCURONIUM BROMIDE
- Product NDC
- 84549-131
- 11-digit product format
- 845490131
- Labeler code
- 84549
- Product ID
- 84549-131_42da65ee-2403-7b51-e063-6394a90a46b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROCURONIUM BROMIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA216234
- Marketing category
- ANDA
- Marketing start
- 2024-10-03
- Substance
- ROCURONIUM BROMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular 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 |
|---|---|---|---|---|---|---|---|
| A216234-001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | |
| A216234-002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216234-001 | AP |
| A216234-002 | 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 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216234-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216234-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2023-03-02 | a67488948f0b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216234-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216234-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216234-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216234-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216234-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216234-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216234-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216234-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216234-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216234-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216234-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216234-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216234-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216234-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216234-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216234-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216234-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216234-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216234-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216234-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216234-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216234-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216234-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216234-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216234-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216234-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216234-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216234-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216234-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216234-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216234-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A216234-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A216234-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A216234-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216234-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216234-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216234-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216234-002 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216234-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216234-002 | AP | 1 | a67488948f0b… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROCURONIUM BROMIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROCURONIUM BROMIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| I65MW4OFHZ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1234995 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 42da65ee-2402-7b51-e063-6394a90a46b7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f63639fe-3389-4c7a-8765-a6005a965c6c | Product name | 9 | 20260316 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 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 |
|---|---|---|---|---|---|---|
| 84549-131-10 | ROCURONIUM BROMIDE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 1 |
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 | 4f9bf2d0-5702-4610-e063-6294a90a2cd9 | 2026-04-16 | Warnings, Adverse reactions | 216234 ANDA216234 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | ProPharma Distribution | 4304f145-24cb-dbe0-e063-6394a90a5dad | 2025-11-07 | Warnings, Adverse reactions | 216234 ANDA216234 |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | ProPharma Distribution | 42da65ee-2402-7b51-e063-6394a90a46b7 | 2025-11-05 | Warnings, Adverse reactions | 216234 ANDA216234 84549-131 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 41b1eb17-c0a4-cf60-e063-6394a90a67e6 | 2025-10-21 | Warnings, Adverse reactions | 216234 ANDA216234 |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Caplin Steriles Limited | f1794318-b058-4254-97b7-d4e07126efbb | 2024-10-03 | Warnings, Adverse reactions | 216234 ANDA216234 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | BE Pharmaceuticals Inc. | 1543ea2b-54ab-4088-a72a-5d71854a2dce | 2023-07-12 | Warnings, Adverse reactions | 216234 ANDA216234 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | PSN | 42da65ee-2402-7b51-e063-6394a90a46b7 | 1 |
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | SCD | 42da65ee-2402-7b51-e063-6394a90a46b7 | 1 |
| 1234995 | rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution | SY | 42da65ee-2402-7b51-e063-6394a90a46b7 | 1 |
| 1234995 | rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution | SY | 42da65ee-2402-7b51-e063-6394a90a46b7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84549-131-10 | 84549013110 | 10 mL in 1 VIAL, MULTI-DOSE (84549-131-10) | 10 ml | 2025-10-10 | No | No | Current |