Prescription medicine
Atracurium First approved as Tracrium
Atracurium (Tracrium) is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the atracurium FDA label on DailyMed (effective December 4, 2024, Meitheal Pharmaceuticals Inc.); the NDA 18831 record on Drugs@FDA; every atracurium label on DailyMed.
Highlights of the record
FDA label of December 4, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAtracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal 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).
On the market
- Earliest approval on file
- November 23, 1983 Tracrium Preservative Free, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first December 23, 1996; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2015 0 Class I among all firms' recalls; latest February 23, 2015
- FAERS reports
- 703 through July 30, 2026
What is atracurium used for?
From the label: indications and usageAtracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
FDA pharmacologic class: Nondepolarizing Neuromuscular Blocker.
Source: FDA drug label (Atracurium Besylate), Meitheal Pharmaceuticals Inc., effective December 4, 2024 (SPL set efe90ee2-fe9e-421f-9e54-2961085d3b12), via openFDA; the full label on DailyMed
Is there a generic for atracurium (Tracrium)?
The FDA approved the first generic atracurium on December 23, 1996. 22 generic applications are approved; 6 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 atracurium from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1983 earliest approval on file
- 1996 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has atracurium been recalled?
The FDA's Enforcement Report lists 2 recalls naming atracurium since 2015: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 23, 2015 | Class II | Sagent Pharmaceuticals Inc | Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atracurium label say about other medicines?
The atracurium label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name atracurium. 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 |
|---|---|---|
| Isoflurane | drug interactions | Drug Interactions Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine. |
| Lithium | drug interactions | Drug Interactions Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine. |
| Procainamide | drug interactions | Drug Interactions Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine. |
| Quinidine | drug interactions | Drug Interactions Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine. |
| Succinylcholine | drug interactions | The prior administration of succinylcholine does not enhance the duration, but quickens the onset and may increase the depth, of neuromuscular block induced by atracurium besylate. |
Other labels that name atracurium
Source: FDA drug label (Atracurium Besylate), Meitheal Pharmaceuticals Inc., effective December 4, 2024 (SPL set efe90ee2-fe9e-421f-9e54-2961085d3b12), via openFDA; the full label on DailyMed
What do FAERS reports show for atracurium?
The FDA Adverse Event Reporting System holds 703 reports that list atracurium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 254 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
- Atracurium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other