NDC 63187-521
bupropion 300 mg tablet, extended release
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-354.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Nov 2, 2016 · Class III · Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications; 6 month time point
Lots: a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018 - Aug 3, 2016 · Class III · Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Lots: Lot #: MR3365, Exp. Feb 17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bupropion: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA201567
- On the market since
- Feb 15, 2014
- Package NDCs
63187-521-3063187-521-6063187-521-90- Official label
- DailyMed (National Library of Medicine), updated Jan 1, 2021
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