What is NDC 54879-001?

54879-001 is the product NDC for Ethambutol Hydrochloride, Ethambutol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by STI Pharma LLC.

STI Pharma LLC, NDC labeler code 54879. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ethambutol Hydrochloride NDC 54879-001

NDC codes

FDA NDC Directory

Product NDC (as listed)54879-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54879-0001Add the package segment from the table below.

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: STI Pharma LLCNDC labeler code 54879
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 016320
Marketing start: Dec 15, 2006
Listing expires: Dec 31, 2027
Identifiers: Product ID 54879-001_5115f4a9-63ad-ebc3-e063-6294a90a7ba8SPL ID 5115f4a9-63ad-ebc3-e063-6294a90a7ba8SPL set ID 3f6428d6-3745-4337-ad78-ebfff9f49135RxCUI 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.

Product label

Current FDA label (SPL), effective May 5, 2026.

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 isoniazidETHAMBUTOL 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.

Full label on DailyMed (opens in a new tab)

About NDC 54879-001

What is NDC 54879-001?: 54879-001 is the product NDC for Ethambutol Hydrochloride, Ethambutol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by STI Pharma LLC.
What drug is associated with this NDC?: Ethambutol Hydrochloride.
What is the active ingredient?: Ethambutol hydrochloride.
Who is the labeler?: STI Pharma LLC, NDC labeler code 54879. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ethambutol Hydrochloride NDCs
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 100 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-796	10135-0796-01
Ethambutol Hydrochloride	Ethambutol hydrochloride 400 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-797	10135-0797-01
Ethambutol Hydrochloride	Ethambutol hydrochloride 400 mg/1	Tablet, Film coatedOral	STI Pharma LLC	54879-002	—

All 13 Ethambutol Hydrochloride NDCs

Other NDCs under NDA 016320

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016320
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 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