NDC 16729-434
Daptomycin 350 mg per 7 mL injection, powder, lyophilized, for solution
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) R2101274, Exp. Date 9/30/2023; R2200161, Exp. Date 1/31/2025; R2200506, Exp. Date 1/31/2025; R2200697, Exp. Date 4/30/2025; R2201107, Exp. Date 7/31/2025; b) R2101471, Exp. Date 9/30/2023; R2200588, Exp. Date 4/30/2025; R2201333, Exp. Date 7/31/2025; R2201361, Exp. Date 8/31/2025;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Daptomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 350 mg per 7 mL
- Approval
- ANDA ANDA212667
- On the market since
- Jul 16, 2019
- Package NDCs
16729-434-0516729-434-45- Official label
- DailyMed (National Library of Medicine), updated Oct 9, 2025
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