azithromycin dihydrate NDC 80425-0412

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0412Add 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
80425-0412-1	80425041201	1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACKMarketed from Jul 10, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 dihydrate
Generic name (nonproprietary): azithromycin dihydrate
Active ingredients: Azithromycin dihydrate — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065399
Marketing start: Jul 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4cedSPL ID 1d0e96cf-245e-cfb7-e063-6294a90a4cedSPL set ID 1cec44fa-9597-3e58-e063-6394a90ae326RxCUI 248656, 749780UNII 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

N480425041201 followed by a unit qualifier and the quantity

Package 80425-0412-01. 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 Jul 12, 2024.

Indications (excerpt from the label)

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 ( 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/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065399

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

FDA NDC Directory listings under ANDA 065399
Product	Strength	Form · route	Labeler	Product NDC
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7351
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-862
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4367
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-753