United States · FDA National Drug Code directory
Azithromycin monohydrate
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 68083-199_87bbc473-3fe8-475b-bf73-2e101377977a
- Product NDC
- 68083-199
- Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Composition / generic term
- Azithromycin monohydrate
- Labeler
- Gland Pharma Limited
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20091109
- Source listing expiry
- 20271231
Source-listed ingredients
- AZITHROMYCIN MONOHYDRATE — 500 mg/10mL
These values do not establish equivalence or a dose recommendation.
Packages
- 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL · 68083-199-10
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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