Azithromycin NDC 0781-8090

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-8090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-8090Add 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
0781-8090-03	00781809003	1 DOSE PACK in 1 CARTON (0781-8090-03) / 3 TABLET, FILM COATED in 1 DOSE PACKMarketed from Feb 14, 2019
0781-8090-31	00781809031	30 TABLET, FILM COATED in 1 BOTTLE (0781-8090-31)Marketed from Feb 14, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065212
Marketing start: Nov 14, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0781-8090_fd0d853c-9304-4e6e-be78-74166dbb8126SPL ID fd0d853c-9304-4e6e-be78-74166dbb8126SPL set ID ec619299-e0ef-44dd-acdb-8c53bbfc5b8aRxCUI 248656, 308460, 749780, 749783UNII 5FD1131I7S
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

N400781809003 followed by a unit qualifier and the quantity

Package 00781-8090-03. 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 Jul 30, 2026.

Indications (excerpt from the label)

Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • 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 ) • Urethritis and cervicitis in adults ( 1.1 ) • Genital ulcer disease in men ( 1.1 ) • Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) • Pharyngitis/…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065212

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

FDA NDC Directory listings under ANDA 065212
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8125
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-674