NDC 82804-013
Bupropion Hydrochloride(XL) 300 mg tablet, extended release
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Cipla USA., Inc.'s NDC 69097-876.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| 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 | Tests it and packages it | Problems found, fixed voluntarilyJul 17, 2026 · 4 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Sep 6, 2018 · Class III · InvaGen Pharmaceuticals, Inc.
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Lots: Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20
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 ANDA206556
- On the market since
- Aug 29, 2016
- Package NDCs
82804-013-3082804-013-6082804-013-90- Official label
- DailyMed (National Library of Medicine), updated Sep 1, 2023
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