Azithromycin NDC 76420-589

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-589Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0589Add 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
76420-589-03	76420058903	3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03)Marketed from Sep 1, 2023

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): Azithromycin
Generic name (nonproprietary): azithromycin
Active ingredients: Azithromycin monohydrate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Asclemed USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065223
Marketing start: Jan 6, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2SPL ID 04472220-f8c1-1f1a-e063-6294a90a2bb2SPL set ID 9c44af6d-8a9a-cb4c-e053-2a95a90afdacRxCUI 248656, 308460, 749780, 749783UNII JTE4MNN1MD
Pharmacologic class: Macrolide Antimicrobial

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

N476420058903 followed by a unit qualifier and the quantity

Package 76420-0589-03. 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 1, 2023.

Indications (excerpt from the label)

Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration ( 2 )]. Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065223

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

FDA NDC Directory listings under ANDA 065223
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0599
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-077
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	50111-788
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-189