Active ingredient
Rocuronium
68 finished FDA listings contain Rocuronium as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ROCURONIUM BROMIDE
- Dosage forms
- Injection, Injection, Solution, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 27
- Strengths listed
- 10 mg/ml · 100 mg/10ml · 50 mg/5ml
- Brand names in FDA listings
- Rocuronium
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68139
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 079199 | MYLAN INSTITUTIONAL | 2008-11-26 | 1 |
| ANDA 078519 | HOSPIRA | 2008-11-26 | 5 |
| ANDA 079195 | SANDOZ | 2008-12-05 | 1 |
| ANDA 078651 | FRESENIUS KABI USA | 2008-12-29 | 4 |
| ANDA 091115 | TAMARANG | 2012-08-27 | 6 |
| ANDA 204679 | WEST WARD PHARM CORP | 2017-02-28 | 7 |
| ANDA 206206 | EUGIA PHARMA | 2017-04-12 | 4 |
| ANDA 205656 | GLAND | 2018-04-04 | 10 |
| ANDA 210437 | PIRAMAL CRITICAL | 2019-08-13 | 4 |
| ANDA 212668 | PRINSTON INC | 2022-05-26 | 2 |
| ANDA 216234 | CAPLIN | 2023-03-02 | 8 |
| ANDA 213453 | MEITHEAL | 2023-05-08 | 4 |
| ANDA 215684 | SHANDONG | 2024-07-12 | 2 |
| ANDA 217092 | STERISCIENCE | 2024-07-22 | 1 |
| ANDA 219674 | MANKIND PHARMA | 2025-05-29 | 2 |
| NDA 217472 | FRESENIUS KABI USA | 2025-06-09 | 6 |
| NDA 219108 | B BRAUN MEDICAL | 2025-10-24 | 1 |
Official labeling on DailyMed
- ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC · version 1 · 2026-08-17
- ROCURONIUM BROMIDE INJECTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] · version 1 · 2026-08-17
- ROCURONIUM BROMIDE INJECTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] · version 1 · 2026-08-14
- ROCURONIUM BROMIDE INJECTION [B. BRAUN MEDICAL INC.] · version 5 · 2026-08-07
- ROCURONIUM BROMIDE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] · version 3 · 2026-08-03
- ROCURONIUM BROMIDE INJECTION [PROPHARMA DISTRIBUTION] · version 1 · 2026-07-28
- ROCURONIUM BROMIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 12 · 2026-05-21
- ROCURONIUM BROMIDE INJECTION, SOLUTION [EUGIA US LLC] · version 7 · 2026-05-20
- ROCURONIUM BROMIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] · version 1 · 2026-04-20
- ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.] · version 14 · 2026-04-17
- ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.] · version 29 · 2026-03-11
- ROCURONIUM INJECTION, SOLUTION [BRYANT RANCH PREPACK] · version 101 · 2026-03-05
Showing the 12 most recent of 47 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.