NDC 36000-013
Ondansetron Hydrochloride 2 mg per 1 mL solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Pharmaceuticals India Private Limited | Ahmedabad, India | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionJan 27, 2023 · 9 inspections, 3 with FDA action |
Recalls
- Nov 14, 2023 · Class II · Baxter Healthcare Corporation
Failed pH Specifications
Lots: Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ondansetron: every company that makes it
- Form
- solution
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA078288
- On the market since
- Mar 13, 2013
- Package NDCs
36000-013-01- Official label
- DailyMed (National Library of Medicine), updated Jun 30, 2025
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