NDC 0069-3150
Zithromax 500 mg per 5 mL injection, powder, lyophilized, for solution
On the label: Pfizer Laboratories Div Pfizer Inc.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Ringaskiddy, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections |
| Pharmacia & Upjohn Company LLC | Kalamazoo, MI, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 16, 2023 · 9 inspections |
Recalls
- Jan 2, 2014 · Class III · Pfizer Inc.
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Lots: Lot Number/Expiration Date G81845, Exp 10/03/14 0B0CJ, Exp 02/06/15 G44710, Exp 07/10/15 G65241, Exp 07/11/15 G80003, Exp 10/17/15 G82722, Exp 11/27/15 G93028, G95309, Exp: 01/23/16 G97641, Exp 01/30/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Azithromycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 500 mg per 5 mL
- Approval
- NDA NDA050733
- On the market since
- Jan 30, 1997
- Package NDCs
0069-3150-830069-3150-84- Official label
- DailyMed (National Library of Medicine), updated Jul 24, 2026
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