Azithromycin NDC 62135-704

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-704Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0704Add 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
62135-704-51	62135070451	15 mL in 1 BOTTLE (62135-704-51)Marketed from Mar 7, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 monohydrate — 100 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065488
Marketing start: May 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 62135-704_15af5062-22b6-c8b6-e063-6294a90a7df3SPL ID 15af5062-22b6-c8b6-e063-6294a90a7df3SPL set ID 2c9de2e9-c20c-4660-a272-a22019f9fb02RxCUI 141963, 308459UNII JTE4MNN1MDUPC 0362135705435, 0362135704513, 0362135705527, 0362135705510
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

N462135070451 followed by a unit qualifier and the quantity

Package 62135-0704-51. 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 Apr 9, 2024.

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 065488

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

FDA NDC Directory listings under ANDA 065488
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin monohydrate 200 mg/5mL	SuspensionOral	Chartwell RX, LLC	62135-705