Quick answers
- What is Rocuronium bromide used for?
- The FDA-approved label (Rocuronium Bromide, B. Braun Medical Inc., July 17, 2026) says: “ROCURONIUM BROMIDE INJECTION is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rocuronium bromide have a boxed warning?
- No. None of the 48 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Rocuronium bromide?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Rocuronium bromide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 7, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rocuronium bromide?
- 25 companies list prescription products of Rocuronium bromide in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Fresenius Kabi USA, LLC and HF Acquisition Co LLC, DBA HealthFirst.
What Rocuronium bromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ROCURONIUM BROMIDE INJECTION is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. …
— FDA label: Rocuronium Bromide, B. Braun Medical Inc., effective July 17, 2026. Read the full label on DailyMed →
The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 48 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 67 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medical Purchasing Solutions, LLC9 products
- Fresenius Kabi USA, LLC9 products
- HF Acquisition Co LLC, DBA HealthFirst8 products
- Hospira, Inc.6 products
- Meitheal Pharmaceuticals Inc.4 products
- Baxter Healthcare Corporation4 products
- ProPharma Distribution3 products
- Eugia US LLC2 products
- Gland Pharma Limited2 products
- Lifestar Pharma LLC2 products
- BE Pharmaceuticals Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Piramal Critical Care Inc2 products
- Civica, Inc.2 products
- Shandong New Time Pharmaceutical Co., Ltd.2 products
- Solco Healthcare US, LLC2 products
- Caplin Steriles Limited2 products
- Sandoz Inc1 product
- Phlow Corporation1 product
- Sagent Pharmaceuticals1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- B. Braun Medical Inc.1 product
- Mylan Institutional LLC1 product
- Bryant Ranch Prepack1 product
- Steriscience Specialties Private Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217472 ROCURONIUM BROMIDE | Fresenius Kabi USA | June 9, 2025 | 1, latest July 15, 2026 2026: Labeling |
| NDA219108 ROCURONIUM BROMIDE | B Braun Medical | October 24, 2025 | — |
Generic approvals (16)
- ANDA078519Hospira · November 26, 2008
- ANDA079199Mylan Institutional · November 26, 2008
- ANDA079195Sandoz · December 5, 2008
- ANDA078651Fresenius Kabi USA · December 29, 2008
- ANDA091115Tamarang · August 27, 2012
- ANDA204679West Ward Pharm Corp · February 28, 2017
- ANDA206206Eugia Pharma · April 12, 2017
- ANDA205656Gland · April 4, 2018
- ANDA210437Piramal Critical · August 13, 2019
- ANDA212668Prinston Inc · May 26, 2022
- ANDA216234Caplin · March 2, 2023
- ANDA213453Meitheal · May 8, 2023
- ANDA215684Shandong · July 12, 2024
- ANDA217092Steriscience · July 22, 2024
- ANDA219674Mankind Pharma · May 29, 2025
- ANDA219260Baxter Hlthcare Corp · September 18, 2026
Shortage status
Current shortage · updated October 21, 2026 · first posted February 15, 2023
| Product | Rocuronium Bromide, Injection, 100 mg/10 mL (10 mg/mL) (NDC 0409-5160-10) |
|---|---|
| Availability | Available |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 7, 2024 · Class II · Terminated · D-0371-2024
cGMP Deviations: Products were stored outside the drug label specifications.
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1234995, 2720024, 2720026, 2740933 |
|---|---|
| SPL set ID of the quoted label | a54a79f7-5207-43d8-a139-7d57557caa50 |
| FDA labels (SPL) | 48 |
| FDA applications | NDA217472, NDA219108, 16 ANDA |
| Active ingredients (FDA) | ROCURONIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rocuronium Bromide, B. Braun Medical Inc., effective July 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →