Azithromycin NDC 55695-002

NDC codes

FDA NDC Directory

Product NDC (as listed)55695-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55695-0002Add 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
55695-002-00	55695000200	15 mL in 1 BOTTLE (55695-002-00)Marketed from Dec 28, 2010

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: Powder, For suspension
Route: Oral
Labeler: STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065246
Marketing start: Dec 28, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 55695-002_1287e725-48d5-e23e-e063-6394a90a96acSPL ID 1287e725-48d5-e23e-e063-6394a90a96acSPL set ID 2b821631-0df2-0fb2-e054-00144ff8d46cRxCUI 141963, 308459UNII JTE4MNN1MD
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

N455695000200 followed by a unit qualifier and the quantity

Package 55695-0002-00. 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 Feb 29, 2024.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to modera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065246

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

FDA NDC Directory listings under ANDA 065246
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 100 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-1868
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	Teva Pharmaceuticals USA, Inc.	0093-2026
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	Teva Pharmaceuticals USA, Inc.	0093-2027
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8675
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	55695-003
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-093
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-1527