What is NDC 80425-0431?

80425-0431 is the product NDC for azithromycin dihydrate, Azithromycin dihydrate 250 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for azithromycin dihydrate?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

azithromycin dihydrate NDC 80425-0431

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0431Add 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
80425-0431-1	8042504310180425043101	6 TABLET in 1 BLISTER PACK (80425-0431-1)Marketed from Aug 27, 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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065398
Marketing start: Aug 27, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 80425-0431_20ae1090-cc58-39fd-e063-6294a90adfabSPL ID 20ae1090-cc58-39fd-e063-6294a90adfabSPL set ID 20ae108a-00c5-a984-e063-6394a90aaaaeRxCUI 308460, 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

N480425043101 followed by a unit qualifier and the quantity

Package 80425-0431-01. 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 Aug 27, 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)

About NDC 80425-0431

What is NDC 80425-0431?: 80425-0431 is the product NDC for azithromycin dihydrate, Azithromycin dihydrate 250 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: azithromycin dihydrate.
What is the active ingredient?: Azithromycin dihydrate.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for azithromycin dihydrate?: 42 other product NDCs are listed under this name. See all azithromycin dihydrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other azithromycin dihydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1607	67046-1607-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1502	67046-1502-03
azithromycin dihydrate	Azithromycin dihydrate 600 mg/1	TabletOral	Coupler LLC	67046-1503	67046-1503-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8800	68788-8800-06
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8773	68788-8773-0368788-8773-04
Azithromycin Dihydrate	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4202	70518-4202-00
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	83008-081	83008-0081-06
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4160	70518-4160-0070518-4160-0170518-4160-02+3 more
azithromycin dihydrate	Azithromycin dihydrate 500 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0412	80425-0412-01
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4105	70518-4105-0070518-4105-0170518-4105-02

All 43 azithromycin dihydrate NDCs

Other NDCs under ANDA 065398

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

FDA NDC Directory listings under ANDA 065398
Product	Strength	Form · route	Labeler	Product NDC
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7350
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3374
Azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-742
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0508
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-861
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4356
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-214