Drug
Who makes ethambutol hydrochloride?
7 companies list ethambutol hydrochloride as a human prescription drug. Forms: tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing ethambutol hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Lupin LimitedIndia | tablet | ANDAANDA078939 | 2 | 14 |
| Epic Laboratories, LLCUnited States | tablet, film coated | ANDAANDA075095 | 2 | 3 |
| Marlex Pharmaceuticals, IncUnited States | tablet, film coated | NDANDA016320 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA078939 | 2 | 1 |
| Kanchan Healthcare Inc | tablet, film coated | NDA, NDA AUTHORIZED GENERICNDA016320 | 2 | 0 |
| STI Pharma LLC | tablet, film coated | NDA AUTHORIZED GENERICNDA016320 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA078939 | 1 | 5 |
Bulk ingredient listings
- Cadila Pharmaceuticals LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes ethambutol hydrochloride?
- 7 companies list ethambutol hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Lupin Limited, Epic Laboratories, LLC, Marlex Pharmaceuticals, Inc, RemedyRepack, Inc, Kanchan Healthcare Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ethambutol hydrochloride?
- 4 companies list ethambutol hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies ethambutol hydrochloride active ingredient?
- 1 company lists ethambutol hydrochloride as a bulk ingredient, including Cadila Pharmaceuticals Limited.