azithromycin NDC 0904-7351

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7351Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7351Add 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
0904-7351-04	00904735104	30 BLISTER PACK in 1 CARTON (0904-7351-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2023

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: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065399
Marketing start: May 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0904-7351_4b1ba4ba-50d5-4bcd-bc69-9005c5dc3f8cSPL ID 4b1ba4ba-50d5-4bcd-bc69-9005c5dc3f8cSPL set ID 814abe38-da4a-48af-bf4b-2ce04a5aabd1RxCUI 248656, 308460UNII 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

N400904735104 followed by a unit qualifier and the quantity

Package 00904-7351-04. 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 Sep 2, 2026.

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 ) L…

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	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
azithromycin dihydrate	Azithromycin dihydrate 500 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0412