Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.
NDC 16729-435
Daptomycin 500 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Accord Healthcare Inc..
Where it's made
Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.
Recalls
- Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: R2101282, Exp. Date 9/30/2023; R2101600,Exp. Date 11/30/2024; R2200002, R2200028, R2200116, R2200142, R2200152, Exp. Date 12/31/2024; R2200165, R2200190, Exp. Date 1/31/2025; R2201042, Exp. Date 7/31/2025;
Product details
- Generic drug
- Daptomycin: see every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 500 mg per 10 mL
- Approval
- ANDA ANDA211961
- On the market since
- Jun 24, 2019
- Package NDCs
16729-435-05- Official label
- DailyMed (National Library of Medicine), updated Oct 9, 2025
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