Prescription drug · NDA AUTHORIZED GENERIC
Ethambutol Hydrochloride NDC 85742-005
Ethambutol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Kanchan Healthcare Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85742-005-04 | 85742000504 | 100 TABLET, FILM COATED in 1 BOTTLE (85742-005-04)Marketed from Aug 26, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ethambutol Hydrochloride
- Generic name (nonproprietary)
- ethambutol hydrochloride
- Active ingredients
- Ethambutol hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kanchan Healthcare Inc
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 016320
- Marketing start
- Listing expires
- Identifiers
- Product ID 85742-005_2a57c753-d5e5-4479-845b-614c928d6dc5SPL ID 2a57c753-d5e5-4479-845b-614c928d6dc5SPL set ID e4ccab0e-84ff-447f-82ca-fa0a3989f6b7RxCUI 995599, 995607UNII QE4VW5FO07UPC 0385742005040, 0385742006047
- Pharmacologic class
- Antimycobacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485742000504followed by a unit qualifier and the quantityPackage 85742-0005-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the 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. 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. In patients who have received previous antituberculous therapy, mycobacterial resistance to…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 016320
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-796 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-797 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | STI Pharma LLC | 54879-001 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | STI Pharma LLC | 54879-002 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-006 |