NDC 43353-190
Gabapentin 800 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Exelan Pharmaceuticals, Inc.'s NDC 76282-406.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ascent Pharmaceuticals Inc | Central Islip, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 9, 2024 · 9 inspections |
| InvaGen Pharmaceuticals, Inc | Hauppauge, NY, United States | Makes it and tests it | No problems foundOct 25, 2023 · 18 inspections |
| InvaGen Pharmaceuticals, Inc | Central Islip, NY, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyJul 17, 2026 · 4 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- May 14, 2020 · Class III · InvaGen Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Lots: Lot # NB900413, Exp. 12/2020
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
- Strength
- 800 mg
- Approval
- ANDA ANDA202764
- On the market since
- Nov 2, 2012
- Package NDCs
43353-190-4543353-190-5343353-190-6043353-190-7043353-190-92- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2021
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?