Prescription medicine
Rocuronium First approved as Zemuron
Rocuronium (Zemuron) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 26 generic labelers.
- Generic listed
- In shortage
Check it at the source: the rocuronium FDA label on DailyMed (effective July 16, 2025, Fresenius Kabi USA, LLC); the NDA 20214 record on Drugs@FDA; every rocuronium label on DailyMed.
Highlights of the record
FDA label of July 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRocuronium 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.
Forms and strengths
- 10 mg/ml
- 50 mg/5ml
- 100 mg/10ml
Injection (solution); injection; solution.
On the market
- Earliest approval on file
- March 17, 1994 Zemuron, Organon Usa Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first November 26, 2008; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 26 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 22, 2039 Rocuronium Bromide injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 3 of 26 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 14 since 2015 0 Class I among all firms' recalls; latest March 31, 2025; 6 more by firms not listed as its makers
- FAERS reports
- 11,713 through July 30, 2026
What is rocuronium used for?
From the label: indications and usageRocuronium 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. Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent 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 pharmacologic class: Nondepolarizing Neuromuscular Blocker.
Source: FDA drug label (Rocuronium), Fresenius Kabi USA, LLC, effective July 16, 2025 (SPL set 9a622308-7bda-4ca0-9de5-d6b3b4be3384), via openFDA; the full label on DailyMed
Is there a generic for rocuronium (Zemuron)?
The FDA approved the first generic rocuronium on November 26, 2008. 22 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists rocuronium from 26 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zemuron injection; a patent listed only for Rocuronium Bromide injection runs to July 22, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1994 earliest approval on file
- 2008 first generic approved
- 2039 last listed patent
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is rocuronium in shortage?
The FDA Drug Shortage Database lists 3 of 26 rocuronium presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on February 15, 2023. 23 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9250-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9251-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-92) | Sandoz Inc. | Current | September 18, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-95) | Sandoz Inc. | Current | September 18, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 25021-687-05) | Sagent Pharmaceuticals | Current | September 18, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 63323-426-05) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 63323-426-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 65219-065-05) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has rocuronium been recalled?
The FDA's Enforcement Report lists 20 recalls naming rocuronium since 2015: 0 Class I (the most serious), 20 Class II, 0 Class III; 1 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of rocuronium and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 31, 2025 | Class II | Denver Solutions, LLC DBA Leiters Health | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| February 7, 2024 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP Deviations: Products were stored outside the drug label specifications. |
| September 21, 2023 | Class II | Central Admixture Pharmacy Services Inc not a listed maker | Lack of assurance of sterility: |
| August 17, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles |
| July 17, 2023 | Class II | Central Admixture Pharmacy Services Inc not a listed maker | Lack of assurance of sterility: Lack of validation data for sanitization cycles |
| July 10, 2023 | Class II | New England Life Care, Inc. dba Advanced Compounding … not a listed maker | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. |
| January 6, 2023 | Class II | Nephron Sterile Compounding Center LLC | Lack of Assurance of Sterility |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rocuronium label say about other medicines?
The rocuronium label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name rocuronium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bacitracin | drug interactions | Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Rocuronium Bromide Injection include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). |
| Carbamazepine | drug interactions | As with other nondepolarizing neuromuscular blocking drugs, if Rocuronium Bromide Injection is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of … |
| Colistimethate | drug interactions | Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Rocuronium Bromide Injection include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). |
| Isoflurane | drug interactions | Use of inhalation anesthetics (enflurane > isoflurane > halothane) has been shown to enhance the activity of other neuromuscular blocking agents. |
| Lithium | drug interactions | Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible: |
| Nitrous oxide | drug interactions | Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of Rocuronium Bromide Injection and decrease the average infusion requirement of Rocuronium Bromide Injection by 40% compared to opioid/nitrous oxide/oxygen anesthesia. |
| Phenytoin | drug interactions | As with other nondepolarizing neuromuscular blocking drugs, if Rocuronium Bromide Injection is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of … |
| Procainamide | drug interactions | Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible: |
| Propofol | drug interactions | The use of propofol for induction and maintenance of anesthesia does not alter the clinical duration or recovery characteristics following recommended doses of Rocuronium Bromide Injection. |
| Quinidine | drug interactions | Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible: |
| Succinylcholine | drug interactions | If Rocuronium Bromide Injection is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. |
| Vancomycin | drug interactions | Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Rocuronium Bromide Injection include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). |
Other labels that name rocuronium
Source: FDA drug label (Rocuronium), Fresenius Kabi USA, LLC, effective July 16, 2025 (SPL set 9a622308-7bda-4ca0-9de5-d6b3b4be3384), via openFDA; the full label on DailyMed
What do FAERS reports show for rocuronium?
The FDA Adverse Event Reporting System holds 11,713 reports that list rocuronium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 938 are coded as a death and 4,263 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nondepolarizing neuromuscular blockers
- the pharmacologic class, with prices and generics
- Rocuronium side effects
- the label's list beside FAERS reports
- Rocuronium shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other