NDC 68462-946
Acetylcysteine 200 mg per 1 mL injection, solution
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Immacule Lifesciences Private Limited | Solan, India | Makes it, tests it and packages it | Serious problems, FDA actionSep 18, 2025 · 3 inspections, 1 with FDA action |
| PharmaZell GmbH | Raubling, Germany | Makes the active ingredient | Problems found, fixed voluntarilyJun 30, 2022 · 4 inspections |
Product details
- Generic drug
- Acetylcysteine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 200 mg per 1 mL
- Approval
- ANDA ANDA213693
- On the market since
- Sep 25, 2024
- Package NDCs
68462-946-1268462-946-30- Official label
- DailyMed (National Library of Medicine), updated May 6, 2026
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