Ethambutol Hydrochloride NDC 68084-280

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0280Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68084-280-01	68084028001	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) / 1 TABLET in 1 BLISTER PACK (68084-280-11)Marketed from Dec 16, 2009

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 — 400 mg/1
Dosage form: Tablet
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078939
Marketing start: Dec 16, 2009
Listing expires: Dec 31, 2026
Identifiers: Product ID 68084-280_3f1882fc-606c-8c87-e063-6294a90aa227SPL ID 3f1882fc-606c-8c87-e063-6294a90aa227SPL set ID d32e9865-8edd-4644-9939-62ed119db3efRxCUI 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

N468084028001 followed by a unit qualifier and the quantity

Package 68084-0280-01. 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 Sep 18, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ethambutol hydrochloride 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, i.e., initial treatment, the most frequently used regimens have been the following: Ethambutol plus isoniazid Ethambutol plus isoniazid plus streptomycin In patients who have received previous antituberculous therapy, mycobacterial r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078939

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

FDA NDC Directory listings under ANDA 078939
Product	Strength	Form · route	Labeler	Product NDC
Ethambutol Hydrochloride	Ethambutol hydrochloride 400 mg/1	TabletOral	REMEDYREPACK INC.	70518-2966
Ethambutol Hydrochloride	Ethambutol hydrochloride 100 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-280
Ethambutol Hydrochloride	Ethambutol hydrochloride 400 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-281
Ethambutol Hydrochloride	Ethambutol hydrochloride 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-3662