NDC 82009-072
Gabapentin 800 mg tablet, film coated
On the label: Quallent Pharmaceuticals Health LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it and tests it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Packages it and labels it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Product details
- Generic drug
- Gabapentin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 800 mg
- Approval
- ANDA ANDA200651
- On the market since
- Sep 1, 2023
- Package NDCs
82009-072-05- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2025
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