NDC 53002-1509
Bupropion Hydrochloride (SR) 100 mg tablet, extended release
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Cipla USA., Inc.'s NDC 69097-877.
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
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Mar 15, 2018 · Class III · InvaGen Pharmaceuticals, Inc.
Failed Dissolution Specifications; during stability testing
Lots: Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018 - Mar 15, 2018 · Class III · InvaGen Pharmaceuticals, Inc.
Failed Dissolution Specifications; during stability testing
Lots: a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018
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
- Strength
- 100 mg
- Approval
- ANDA ANDA206674
- On the market since
- Jul 25, 2016
- Package NDCs
53002-1509-6- Official label
- DailyMed (National Library of Medicine), updated Dec 15, 2020
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