Rocuronium Bromide Injection shortage
Rocuronium Bromide Injection is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 6 affected presentations across 2 strengths, first posted 2023-02-15 and last updated 2026-08-20. 4 companies report it — Baxter Healthcare, Mylan Institutional, A Viatris Company, Sagent Pharmaceuticals and Sandoz Inc. — across 6 source lines. The strengths listed are 10 mg/1 mL and 50 mg/5 mL. 12 package NDCs are referenced, under 4 FDA application numbers and 1 substance identifier. The FDA files it under Anesthesia. Neither the FDA record nor RxNorm publishes a brand name for this product, so none is shown. Every line is reproduced below with its company, presentation, package NDC and the FDA's own availability text, so each can be checked individually. Confirm the live status at the official FDA shortage record before relying on it: this page is regulatory supply information only, it is not medical advice, it does not assess clinical impact, and it never suggests a substitute.
Regulatory snapshot
| FDA shortage status | Current |
|---|---|
| Since (first posted) | 2023-02-15 |
| Last updated | 2026-08-20 |
| Affected presentations | 6 |
| Strengths listed | 2 (10 mg/1 mL, 50 mg/5 mL) |
| Reporting manufacturers | 4 |
| Brand names | None in FDA or RxNorm data |
| Generic name | Rocuronium Bromide Injection |
| Product form | Injection |
| Therapeutic category | Anesthesia |
| Package NDCs listed | 12 |
| openFDA source rows | 6 |
| Official source | https://www.accessdata.fda.gov/scripts/drugshortages/ |
Affected presentations, companies and availability
The FDA publishes one line per reported package presentation and reporting company. All 6 line(s) behind this entry are reproduced below — company, presentation, strength, package NDC, status, the agency's availability text verbatim, and the date each line was last updated — so any single line can be checked against the official record without leaving this page. No line becomes a page of its own.
| Reporting company | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Mylan Institutional, A Viatris Company | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-10) | 10 mg/1 mL | 67457-228-10 | Current | Available | 2026-08-20 |
| Sagent Pharmaceuticals | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 25021-687-05) | 10 mg/1 mL | 25021-687-05 | Current | Available | 2026-08-18 |
| Sandoz Inc. | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-95) | 10 mg/1 mL | 0781-3220-95 | Current | Available | 2026-08-18 |
| Sandoz Inc. | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-92) | 10 mg/1 mL | 0781-3220-92 | Current | Available | 2026-08-18 |
| Mylan Institutional, A Viatris Company | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-05) | 10 mg/1 mL | 67457-228-05 | Current | Available | 2026-08-20 |
| Baxter Healthcare | Rocuronium Bromide, Injection, 50 mg/5 mL (NDC 43066-007-10) | 50 mg/5 mL | 43066-007-10 | Current | Available | 2026-08-17 |
FDA application number(s) recorded against the affected products: ANDA079195, ANDA079199, ANDA091115, ANDA205656. Substance identifier(s) (UNII): I65MW4OFHZ.
Reporting manufacturers (4)
Each company below filed at least one of the source lines above. The record counts shown are coverage-limited activity signals from the indexed datasets — never quality ratings.
| Company | Lines filed here | Indexed records | Recalls | Shortage entries |
|---|---|---|---|---|
| Baxter Healthcare | 1 | 14 | 0 | 14 |
| Mylan Institutional, A Viatris Company | 2 | 6 | 0 | 6 |
| Sagent Pharmaceuticals | 1 | 6 | 1 | 5 |
| Sandoz Inc. | 2 | 4 | 1 | 3 |
Related shortages
Every link below comes from a relation in the FDA data itself — a shared substance identifier, a shared reporting company, or a shared FDA therapeutic category — ordered by the strength of that overlap. Nothing here is a popularity list or an editorial suggestion.
Reported by the same companies
- Clindamycin Phosphate Injection · Current · updated 2026-08-18 · 3 shared reporting companies
- Dexmedetomidine Hydrochloride Injection · Current · updated 2026-08-20 · 2 shared reporting companies
- Ketorolac Tromethamine Injection · Current · updated 2026-08-18 · 2 shared reporting companies
- Bumetanide Injection · Current · updated 2026-08-21 · 1 shared reporting company
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet · Current · updated 2026-08-20 · 1 shared reporting company
- Dexamethasone Sodium Phosphate Injection · Current · updated 2026-08-20 · 1 shared reporting company
- Etomidate Injection · Current · updated 2026-08-20 · 1 shared reporting company
- Remifentanil Hydrochloride Injection · Current · updated 2026-08-20 · 1 shared reporting company
Same FDA therapeutic category
- Atropine Sulfate Injection · Current · updated 2026-08-18 · 1 shared category
- Bupivacaine Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
- Lidocaine Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
- Midazolam Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
- Ropivacaine Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
How to interpret this shortage record
A drug-shortage entry means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. Because the FDA publishes one line per reported package and reporting company, this page consolidates 6 such lines into the single shortage they describe; each line remains listed below with its own company, presentation and availability text so it can be checked individually against the source. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.
What an FDA shortage entry is
A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. It names the affected product, attributes the report to the companies shown above, and records a status marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The FDA publishes one line per reported package presentation and reporting company, so this entry is assembled from 6 such lines rather than one page per line. The earliest initial posting date across them is 2023-02-15, and the latest update 2026-08-20. The FDA files this product under Anesthesia in its own therapeutic categorisation, which is reproduced here as a source field and carries no clinical meaning on this page. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind.
Why this page has one address
This page's address is derived from the shortage's own identity — the product name as the FDA publishes it, including the form in which it is supplied — and not from the entry's status, from the reporting company, or from the order in which the openFDA API happened to return its rows. That means the address stays the same when the status changes from current to resolved, when another company is added to the same shortage, or when a further package presentation is reported. Distinct product forms of the same molecule — an injection and an oral capsule, say — remain distinct pages, because the FDA tracks them as separate shortages. 9 earlier addresses for this entry redirect here permanently, so previously published links continue to resolve.
What this record does not mean
This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.
Source-row notes
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Rocuronium Bromide Injection, a product manufactured by Mylan Institutional, A Viatris Company. It is presented as an injection containing 10 mg of Rocuronium Bromide per 1 mL, with the National Drug Code (NDC) 67457-228-10. The product is currently available and is related to anesthesia. The initial posting date of this record is February 15, 2023, with the last update scheduled for August 20, 2026.
Regulatory context
The status 'Current' indicates that the product is actively available in the market. The classification as 'Available' signifies that it can be obtained by healthcare providers or institutions for use. This information is regulatory in nature and does not imply any medical advice.
The summary was derived from the fields: generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were omitted.
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Rocuronium Bromide Injection, a medication presented as an injection with a concentration of 10 mg per 1 mL. It is manufactured by Mylan Institutional, a Viatris Company, and is currently available for use. The record includes information on its initial posting date and the last updated date, indicating ongoing regulatory oversight.
Regulatory context
The status of 'Current' indicates that this product is actively monitored and available in the market. The classification as 'Available' signifies that it can be obtained by healthcare providers. The record reflects compliance with FDA regulations as of the last update.
Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.
How to read this data
Where to go next
- All indexed FDA drug shortages — the full shortage hub with status counts.
- Current FDA drug shortages — every entry with an active status.
- Manufacturer regulatory signals — recall and shortage activity by firm.
- FDA drug recalls — the enforcement-report side of the same datasets.
- Regulatory guides — how these records work and how to verify them.
- Methodology and FDA data sources — how this entry was built.
- Glossary and dataset freshness — definitions and currency.
Source & provenance
- Official source
- https://www.accessdata.fda.gov/scripts/drugshortages/
- Source dataset
- openFDA Drug Shortages API
- Publication date
- 2023-02-15
- Ingested
- 2026-08-22
- Record hash
83e143c8dcd789d7
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.