NDC 0338-1047
Nitroglycerin In Dextrose 10 mg per 100 mL injection
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Cleveland, MS, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionSep 29, 2025 · 9 inspections, 3 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Nov 18, 2013 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Lots: G105197, Exp. 02/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nitroglycerin: every company that makes it
- Form
- injection, intravenous
- Strength
- 10 mg per 100 mL
- Approval
- NDA NDA019970
- On the market since
- Dec 29, 1989
- Package NDCs
0338-1047-02- Official label
- DailyMed (National Library of Medicine), updated Aug 22, 2016
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