Prescription drug · NDA
Ethambutol Hydrochloride NDC 10135-796
Ethambutol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-796-01 | 1013507960110135079601 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-796-01)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
- Marlex Pharmaceuticals, Inc.NDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016320
- Marketing start
- Listing expires
- Identifiers
- Product ID 10135-796_2dcb6b41-b9a8-4dde-8248-334d13f87a29SPL ID 2dcb6b41-b9a8-4dde-8248-334d13f87a29SPL set ID 1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1RxCUI 995599, 995607UNII QE4VW5FO07
- 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
N410135079601followed by a unit qualifier and the quantityPackage 10135-0796-01. 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.
About NDC 10135-796
- What is NDC 10135-796?
- 10135-796 is the product NDC for Ethambutol Hydrochloride, Ethambutol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethambutol Hydrochloride.
- What is the active ingredient?
- Ethambutol hydrochloride.
- Who is the labeler?
- Marlex Pharmaceuticals, Inc., NDC labeler code 10135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethambutol Hydrochloride?
- 12 other product NDCs are listed under this name. See all Ethambutol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ethambutol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3662 | 70518-3662-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2966 | 70518-2966-00 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-101 | 42806-0101-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-102 | 42806-0102-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | American Health Packaging | 68084-280 | 68084-0280-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-280 | 68180-0280-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-281 | 68180-0281-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-797 | 10135-0797-01 |
| 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 | — |
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 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 100 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-005 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-006 |