Medicine
Ethambutol 400 mg tablet
Ethambutol 400 mg tablet is a generic prescription medicine for oral use, made by 7 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at controlled room temperature 20° to 25° C (68° to 77° F).
Key facts
- Active ingredient (INN)
- Ethambutol
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 100 blister pack, 30 tablets and 3 more
- Manufacturers
- LupinIndiaAmerican Health PackagingEpic PharmaKanchan HealthcareMarlex PharmaceuticalsRemedyrepack7 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20° to 25° C (68° to 77° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J04AK02 Ethambutol
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 December 2006
- Identifiers
- RxCUI 995599, 995607DailyMed set ID 1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1, c12b3482-55f0-4324-bdcd-b129ca2dae73, d32e9865-8edd-4644-9939-62ed119db3ef +4NDC 10135-797, 70518-2966, 68084-280 +4Application NDA016320, ANDA078939, ANDA075095
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 68180-281-01 | LupinIndia | 4 July 2009 |
| 100 tablet, film coated in 1 bottle | 42806-102-01 | Epic Pharma | 30 July 2020 |
| 100 tablet, film coated in 1 bottle | 85742-006-04 | Kanchan Healthcare | 26 August 2025 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-280-01 | American Health Packaging | 16 December 2009 |
| 100 tablet, film coated in 1 bottle | 10135-797-01 | Marlex Pharmaceuticals | 26 August 2025 |
| 30 tablet in 1 blister pack | 70518-2966-0 | Remedyrepack | 11 December 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 6 November 1967 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Ethambutol
Clinical summary
Ethambutol is an antimycobacterial indicated for the treatment of pulmonary tuberculosis. It is available as tablets for oral use. MedsAcross supplies Ethambutol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about EthambutolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ethambutol Hydrochloride prescribing information (STI Pharma) · U.S. National Library of Medicine, DailyMed
Need Ethambutol 400 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.