Quick answers
- What is Ethambutol hydrochloride used for?
- The FDA-approved label (Ethambutol Hydrochloride, STI Pharma LLC, May 5, 2026) says: “INDICATIONS ETHAMBUTOL 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ethambutol hydrochloride have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ethambutol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ethambutol hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 22, 2013 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Ethambutol hydrochloride?
- 7 companies list prescription products of Ethambutol hydrochloride in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., Epic Pharma, LLC and STI Pharma LLC.
What Ethambutol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS ETHAMBUTOL 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. …
— FDA label: Ethambutol Hydrochloride, STI Pharma LLC, effective May 5, 2026. Read the full label on DailyMed →
The FDA has 7 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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 13 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethambutol hydrochloride 100 mg tablet | Generic | $0.3008 per tablet |
| ethambutol hydrochloride 100 mg tablet, film coated | Generic | $0.3008 per tablet |
| ethambutol hydrochloride 400 mg tablet | Generic | $0.4683 per tablet |
| ethambutol hydrochloride 400 mg tablet, film coated | Generic | $0.4683 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Lupin Pharmaceuticals, Inc.2 products
- Epic Pharma, LLC2 products
- STI Pharma LLC2 products
- Kanchan Healthcare Inc2 products
- Marlex Pharmaceuticals, Inc.2 products
- Remedyrepack Inc.2 products
- American Health Packaging1 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 |
|---|---|---|---|
| NDA016320 MYAMBUTOL | Kanchan Hlthcare | November 6, 1967 | 33, latest February 22, 2013 2013: Manufacturing (CMC) · 2008: Labeling · 2004: Labeling |
Generic approvals (2)
- ANDA075095Epic Pharma LLC · November 30, 1999
- ANDA078939Lupin · June 17, 2009
Shortage status
The FDA drug shortage list does not show these products.
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 22, 2013 · Class III · Terminated · D-346-2014
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC — Lupin Pharmaceuticals Inc.
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) | 995599, 995607 |
|---|---|
| SPL set ID of the quoted label | 3f6428d6-3745-4337-ad78-ebfff9f49135 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA016320, 2 ANDA |
| Active ingredients (FDA) | ETHAMBUTOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ethambutol Hydrochloride, STI Pharma LLC, effective May 5, 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 →