azithromycin NDC 0527-2395

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-2395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-2395Add 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
0527-2395-19	00527239519	1 BLISTER PACK in 1 CARTON (0527-2395-19) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 4, 2019
0527-2395-32	00527239532	30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32)Marketed from Jul 4, 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: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209044
Marketing start: Jul 4, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0527-2395_371e26cf-af95-77d5-e063-6294a90a34b5SPL ID 371e26cf-af95-77d5-e063-6294a90a34b5SPL set ID a2b0c06b-e93d-f5aa-e053-2995a90ac9aaRxCUI 248656, 308460, 749780, 749783UNII 5FD1131I7SUPC 0305272370203
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

N400527239519 followed by a unit qualifier and the quantity

Package 00527-2395-19. 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 May 13, 2025.

Indications (excerpt from the label)

Azithromycin is 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 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 ) Urethritis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209044

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

FDA NDC Directory listings under ANDA 209044
Product	Strength	Form · route	Labeler	Product NDC
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-726