NDC 0904-7108
Gabapentin 800 mg tablet, film coated
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals 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 |
Recalls
- Apr 24, 2023 · Class III · The Harvard Drug Group
Product mixup: one foreign tablet found in product.
Lots: Lot: T04468, Exp 10/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
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
- Oct 6, 2011
- Package NDCs
0904-7108-61- Official label
- DailyMed (National Library of Medicine), updated May 4, 2026
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