Azithromycin NDC 46708-253

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0253Add 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
46708-253-10	46708025310	100 BLISTER PACK in 1 CARTON (46708-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 28, 2020
46708-253-30	46708025330	30 TABLET, FILM COATED in 1 BOTTLE (46708-253-30)Marketed from Jan 28, 2020

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 dihydrate — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211793
Marketing start: Jan 28, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2dSPL ID 6a2f7a6c-a45d-448d-8f56-5bd7a5309a2dSPL set ID 5dca5a11-3c02-4a51-a35d-f91f37b8e00cRxCUI 204844UNII 5FD1131I7SUPC 0346708253301
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

N446708025310 followed by a unit qualifier and the quantity

Package 46708-0253-10. 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 27, 2023.

Indications (excerpt from the label)

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. Azithromycin tablets are a macrolide antibacterial drug 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)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211793

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

FDA NDC Directory listings under ANDA 211793
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-253