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Azithromycin monohydrate

NDC 68083-199 · Gland Pharma Limited

Generic nameAzithromycin monohydrate
Dosage formINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
RouteINTRAVENOUS
Active ingredient(s)AZITHROMYCIN MONOHYDRATE
Strength500 mg/10mL
Pharmacologic classMacrolide Antimicrobial [EPC], Macrolides [CS]
Marketing categoryANDA

Packages

68083-199-10 — 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

62756-512 — Azithromycin, 63187-007 — Azithromycin, 63187-093 — Azithromycin, 63187-189 — Azithromycin, 63323-398 — AZITHROMYCIN MONOHYDRATE, 68071-1527 — Azithromycin, 68071-3897 — azithromycin, 68071-4773 — AZITHROMYCIN, 68071-4795 — AZITHROMYCIN, 68071-5035 — AZITHROMYCIN, 68788-7549 — AZITHROMYCIN, 68788-8675 — Azithromycin, 70095-025 — Azithromycin monohydrate, 70518-0599 — Azithromycin, 70518-0784 — Azithromycin, 70860-100 — azithromycin monohydrate, 70860-125 — azithromycin monohydrate, 71205-253 — AZITHROMYCIN, 71205-566 — AZITHROMYCIN, 72189-314 — AZITHROMYCIN, +28 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

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