Azithromycin NDC 46708-058

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-058Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0058Add 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
46708-058-03	46708005803	3 BLISTER PACK in 1 CARTON (46708-058-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2020
46708-058-30	46708005830	30 TABLET, FILM COATED in 1 BOTTLE (46708-058-30)Marketed from Jan 29, 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 — 500 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 211792
Marketing start: Jan 29, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 46708-058_ea5ea4f7-a4ce-4644-860a-942898f50a8aSPL ID ea5ea4f7-a4ce-4644-860a-942898f50a8aSPL set ID d5c95c30-564f-4b67-ac6d-9179cdfaa5a8RxCUI 248656, 749780UNII 5FD1131I7SUPC 0346708058302
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

N446708005803 followed by a unit qualifier and the quantity

Package 46708-0058-03. 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 13, 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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)]. Azithromycin tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211792

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

FDA NDC Directory listings under ANDA 211792
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3254
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-252