NDC 33261-116
Gabapentin 800 mg tablet, film coated
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Aurobindo Pharma Limited's NDC 65862-524.
Where the pills inside were 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
- Strength
- 800 mg
- Approval
- ANDA ANDA200651
- On the market since
- Oct 6, 2011
- Package NDCs
33261-116-0033261-116-0233261-116-1033261-116-2033261-116-2133261-116-3033261-116-4233261-116-4533261-116-6033261-116-8133261-116-9033261-116-97- Official label
- DailyMed (National Library of Medicine), updated Sep 26, 2012
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