NDC 16571-863
bupropion hydrochloride 300 mg tablet, extended release
On the label: Rising Pharma Holdings, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Graviti Pharmaceuticals Private Limited | Sangareddy, India | Makes it and tests it | Problems found, fixed voluntarilyJul 28, 2026 · 2 inspections |
Recalls
- Sep 15, 2025 · Class II · Graviti Pharmaceuticals Private Limited
Failed Tablet/Capsule Specifications
Lots: Batch # BPB124341A, Exp date: 10/2026
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 ANDA211020
- On the market since
- Aug 1, 2022
- Package NDCs
16571-863-0316571-863-0916571-863-1016571-863-50- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2026
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