Rocuronium Bromide
- Product NDC
- 0143-9250
- 11-digit product format
- 001439250
- Labeler code
- 0143
- Product ID
- 0143-9250_51fc5473-b651-4c85-83ff-7edc65a6cef2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rocuronium Bromide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA204679
- Marketing category
- ANDA
- Marketing start
- 2017-04-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204679-001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | |
| A204679-002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204679-001 | AP |
| A204679-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204679-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204679-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2017-02-28 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204679-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204679-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204679-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204679-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204679-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204679-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204679-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204679-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204679-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204679-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204679-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204679-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204679-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204679-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204679-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204679-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204679-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204679-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204679-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204679-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204679-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204679-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204679-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204679-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204679-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204679-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204679-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204679-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204679-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A204679-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204679-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204679-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204679-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204679-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204679-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204679-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204679-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204679-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204679-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204679-002 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rocuronium Bromide
- Listing expiration
- 2027-12-31
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 |
|---|---|
| d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9250-01 | Rocuronium Bromide | 5 mL in 1 VIAL | INJECTION | 5 | 12 | |
| 0143-9250-10 | Rocuronium Bromide | 10 in 1 BOX | INJECTION | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9250-01 | ML - Milliliter | 0143-9250 | c9d5ffff-78a0-4555-85ef-bce4ab3c65d4 | 1 | 2019-08-06 |
| 0143-9250-10 | ML - Milliliter | 0143-9250 | 713ef38b-121d-4166-8ee7-57d72b593e06 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
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 | HF Acquisition Co. LLC, DBA HealthFirst | 58ce3f40-cbb9-db9e-e063-6394a90ae611 | 2026-08-11 | Warnings, Adverse reactions | 204679 ANDA204679 |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | HF Acquisition Co. LLC, DBA HealthFirst | 58b92bce-5ff8-6741-e063-6294a90a25e9 | 2026-08-10 | Warnings, Adverse reactions | 204679 ANDA204679 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Civica, Inc. | 8ea475c7-d35e-47f4-8955-0df5ccd35b79 | 2025-07-28 | Warnings, Adverse reactions | 204679 ANDA204679 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 15ea777f-2ba9-7f60-e063-6294a90a539b | 2024-04-12 | Warnings, Adverse reactions | 204679 ANDA204679 |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Hikma Pharmaceuticals USA Inc. | d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | 2023-05-20 | Warnings, Adverse reactions | 204679 ANDA204679 0143-9250 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | PSN | d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | 12 |
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | SCD | d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | 12 |
| 1234995 | rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution | SY | d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | 12 |
| 1234995 | rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution | SY | d3a172a5-01ab-47d8-92ac-a8539b1d4dc4 | 12 |
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | PSN | 15ea777f-2ba9-7f60-e063-6294a90a539b | 1 |
| 1234995 | rocuronium bromide 10 MG/ML Injectable Solution | SCD | 15ea777f-2ba9-7f60-e063-6294a90a539b | 1 |
| 1234995 | rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution | SY | 15ea777f-2ba9-7f60-e063-6294a90a539b | 1 |
| 1234995 | rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution | SY | 15ea777f-2ba9-7f60-e063-6294a90a539b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9250-01 | 00143925001 | 5 mL in 1 VIAL | 5 ml | Historical | ||||
| 0143-9250-10 | 00143925010 | 10 VIAL in 1 BOX (0143-9250-10) / 5 mL in 1 VIAL (0143-9250-01) | 10 vial | 2017-04-30 | 0000-00-00 | No | No | Current |