azithromycin dihydrate NDC 67046-1503

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1503Add 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
67046-1503-3	67046150303	30 TABLET in 1 BLISTER PACK (67046-1503-3)Marketed from Jan 28, 2025

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 — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Coupler LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065400
Marketing start: Jan 28, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 67046-1503_2cc9449e-e4be-3667-e063-6294a90af6baSPL ID 2cc9449e-e4be-3667-e063-6294a90af6baSPL set ID 2cc93e72-95ce-965b-e063-6394a90a8917RxCUI 204844UNII 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

N467046150303 followed by a unit qualifier and the quantity

Package 67046-1503-03. 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 Jan 28, 2025.

Indications (excerpt from the label)

Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) Azithromycin tablets are 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. 1.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065400

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

FDA NDC Directory listings under ANDA 065400
Product	Strength	Form · route	Labeler	Product NDC
azithromycin	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-863