Azithromycin NDC 42291-083

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0083Add 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
42291-083-03	42291008303	3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03)Marketed from Apr 11, 2022
42291-083-30	42291008330	30 TABLET, FILM COATED in 1 BOTTLE (42291-083-30)Marketed from Apr 11, 2022

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 dihydrate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210001
Marketing start: Apr 11, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 42291-083_4d3a5007-c37f-70b6-e063-6394a90acf0cSPL ID 4d3a5007-c37f-70b6-e063-6394a90acf0cSPL set ID dc633b7d-5154-7e43-e053-2a95a90ad2a6RxCUI 248656, 308460UNII 5FD1131I7SUPC 0342291083301, 0342291082304
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

N442291008303 followed by a unit qualifier and the quantity

Package 42291-0083-03. 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 Mar 17, 2026.

Indications (excerpt from the label)

Azithromycin tablets are 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 is 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 ( 1.1 ) Ur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210001

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

FDA NDC Directory listings under ANDA 210001
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	DIRECT RX	72189-088
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2297
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-503
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-172
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1755