Prescription medicine
Ethambutol First approved as Myambutol
Ethambutol (Myambutol) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.458 per ethambutol HCl 400 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ethambutol FDA label on DailyMed (effective November 21, 2025, Kanchan Healthcare Inc); the NDA 16320 record on Drugs@FDA; every ethambutol label on DailyMed.
Highlights of the record
FDA label of November 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageETHAMBUTOL HCl is indicated for the treatment of pulmonary tuberculosis.
Forms and strengths
- 100 mg
- 400 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- November 6, 1967 Myambutol, Kanchan Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first November 30, 1999; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 4 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.458 per tablet Ethambutol HCl 400 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest March 18, 2013
- FAERS reports
- 2,668 through July 30, 2026
What is ethambutol used for?
From the label: indications and usageETHAMBUTOL HCl is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following: ETHAMBUTOL HCl plus isoniazid ETHAMBUTOL HCl plus isoniazid plus streptomycin. […]
FDA pharmacologic class: Antimycobacterial.
Source: FDA drug label (Ethambutol Hydrochloride), Kanchan Healthcare Inc, effective November 21, 2025 (SPL set e4ccab0e-84ff-447f-82ca-fa0a3989f6b7), via openFDA; the full label on DailyMed
Is there a generic for ethambutol (Myambutol)?
The FDA approved the first generic ethambutol on November 30, 1999. 3 generic applications are approved; 2 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 ethambutol from 4 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.
- 1967 earliest approval on file
- 1999 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethambutol (Myambutol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.458 per Ethambutol HCl 400 mg tablet, down 1% from $0.465 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ethambutol HCl 400 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ethambutol HCl 100 mg tablet | Generic | $0.304 per tablet | $9.12 | -12% |
| Ethambutol HCl 400 mg tablet | Generic | $0.458 per tablet | $13.74 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ethambutol been recalled?
The FDA's Enforcement Report lists 2 recalls naming ethambutol since 2013: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 18, 2013 | Class II | West-ward Pharmaceutical Corp. | Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. |
| February 22, 2013 | Class III | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ethambutol label say about other medicines?
The ethambutol label names no other medicine on this site. The labels of 3 other medicines name ethambutol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Ethambutol Hydrochloride), Kanchan Healthcare Inc, effective November 21, 2025 (SPL set e4ccab0e-84ff-447f-82ca-fa0a3989f6b7), via openFDA; the full label on DailyMed
What do FAERS reports show for ethambutol?
The FDA Adverse Event Reporting System holds 2,668 reports that list ethambutol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 331 are coded as a death and 1,090 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 antimycobacterials
- the pharmacologic class, with prices and generics
- Ethambutol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other