Ethambutol Hydrochloride NDC 42806-101

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0101Add 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
42806-101-01	42806010101	100 TABLET, FILM COATED in 1 BOTTLE (42806-101-01)Marketed from Jul 30, 2020

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: Epic Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075095
Marketing start: Mar 18, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 42806-101_a5247287-041a-4548-9a24-aadbfd233459SPL ID a5247287-041a-4548-9a24-aadbfd233459SPL set ID 08decdf3-a397-42e7-8ac3-e489c0cc7085RxCUI 995599, 995607UNII QE4VW5FO07UPC 0342806101018, 0342806102015
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

N442806010101 followed by a unit qualifier and the quantity

Package 42806-0101-01. 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 Nov 8, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ethambutol Hydrochloride Tablets, USP are 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 hydrochloride, USP plus isoniazid Ethambutol hydrochloride, USP plus isoniazid plus streptomycin In patients who have recei…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075095

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

FDA NDC Directory listings under ANDA 075095
Product	Strength	Form · route	Labeler	Product NDC
Ethambutol Hydrochloride	Ethambutol hydrochloride 400 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-102