Ascent Pharmaceuticals Inc
Central Islip, NY, United States · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Aug 9, 2024. 9 inspections on record.
NDC 76282-406
Gabapentin 800 mg tablet, film coated
On the label: Exelan Pharmaceuticals, Inc..
Where it's made
InvaGen Pharmaceuticals, Inc
Hauppauge, NY, United States · makes it and tests it
No problems found Last FDA inspection Oct 25, 2023. 18 inspections on record.
InvaGen Pharmaceuticals, Inc
Central Islip, NY, United States · makes it, tests it and packages it
Problems found, fixed voluntarily Last FDA inspection Jul 17, 2026. 4 inspections on record.
Recalls
- May 14, 2020 · Class III · Terminated
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Lots: Lot # NB900413, Exp. 12/2020
Product details
- Generic drug
- Gabapentin: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 800 mg
- Approval
- ANDA ANDA202764
- On the market since
- Nov 2, 2012
- Package NDCs
76282-406-0176282-406-0576282-406-3076282-406-90- Official label
- DailyMed (National Library of Medicine), updated Mar 23, 2023
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