Zithromax (azithromycin dihydrate) NDC 0069-3120

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-3120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-3120Add 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
0069-3120-19	00069312019	1 BOTTLE in 1 CARTON (0069-3120-19) / 15 mL in 1 BOTTLEMarketed from Oct 19, 1995

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): Zithromax
Generic name (nonproprietary): azithromycin dihydrate
Active ingredients: Azithromycin dihydrate — 200 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050710
Marketing start: Oct 19, 1995
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0069-3120_1c5f0fcc-88ce-47e9-a128-b7326b7a5a02SPL ID 1c5f0fcc-88ce-47e9-a128-b7326b7a5a02SPL set ID db52b91e-79f7-4cc1-9564-f2eee8e31c45RxCUI 105260, 141963, 211307, 212446, 226827, 248656, 308459, 308460, 749780, 749783, 750149, 750157UNII 5FD1131I7SUPC 0300693060306, 0300693070305
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

N400069312019 followed by a unit qualifier and the quantity

Package 00069-3120-19. 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 Jul 24, 2026.

Indications (excerpt from the label)

ZITHROMAX is 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/tonsillitis …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050710

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

FDA NDC Directory listings under NDA 050710
Product	Strength	Form · route	Labeler	Product NDC
Zithromaxazithromycin dihydrate	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	Pfizer Laboratories Div Pfizer Inc	0069-3140
Zithromaxazithromycin dihydrate	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	Pfizer Laboratories Div Pfizer Inc	0069-3130