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Azithromycin

NDC 63323-398 · Fresenius Kabi USA, LLC

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic nameAZITHROMYCIN MONOHYDRATE
Dosage formINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
RouteINTRAVENOUS
Active ingredient(s)AZITHROMYCIN MONOHYDRATE
Strength500 mg/5mL
Pharmacologic classMacrolide Antimicrobial [EPC], Macrolides [CS]
Marketing categoryANDA

Packages

63323-398-10 — 10 VIAL in 1 TRAY (63323-398-10) / 5 mL in 1 VIAL (63323-398-01)

63323-398-14 — 10 VIAL in 1 TRAY (63323-398-14) / 5 mL in 1 VIAL (63323-398-41)

Billed under HCPCS

J0456 — Injection, azithromycin, 500 mg Medicare Part B payment limit (ASP + 6%): $2.57

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

54348-857 — AZITHROMYCIN MONOHYDRATE, 55150-174 — Azithromycin, 55695-002 — Azithromycin, 55695-003 — Azithromycin, 62135-704 — Azithromycin, 62135-705 — Azithromycin, 62756-512 — Azithromycin, 63187-007 — Azithromycin, 63187-093 — Azithromycin, 63187-189 — Azithromycin, 68071-1527 — Azithromycin, 68071-3897 — azithromycin, 68071-4773 — AZITHROMYCIN, 68071-4795 — AZITHROMYCIN, 68071-5035 — AZITHROMYCIN, 68083-199 — Azithromycin monohydrate, 68788-7549 — AZITHROMYCIN, 68788-8675 — Azithromycin, 70095-025 — Azithromycin monohydrate, 70518-0599 — Azithromycin, +28 more

Poisoning, adverse-effect and underdosing codes for this drug

The ICD-10-CM Table of Drugs and Chemicals carries these diagnosis codes for this drug — a drug-name match derived from FDA's product name and the Table of Drugs and Chemicals, not a CMS-published pairing.

T36.3X1 — Poisoning by macrolides, accidental (unintentional), T36.3X2 — Poisoning by macrolides, intentional self-harm, T36.3X3 — Poisoning by macrolides, assault, T36.3X4 — Poisoning by macrolides, undetermined, T36.3X5 — Adverse effect of macrolides, T36.3X6 — Underdosing of macrolides

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q4 (October 2026 release). All data sources · How to read the labels

Current data releases:ICD-10-CM FY2027 · ICD-10-PCS FY2027 · HCPCS October 2026 · MS-DRG v44 · Medicare Code Editor v44.0 · NCCI PTP Q4 2026 · MUE Q4 2026 · NCD code lists 2026-01 · LCD export September 28, 2026 · All releases and sources