NDC 61919-806
Pantoprazole Sodiumdr 20 mg tablet, delayed release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Torrent Pharma, Inc.'s NDC 13668-096.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Apr 11, 2022 · Class II · Torrent Pharma Inc
CGMP deviations: tablets cracking
Lots: Lot #s: BA34G021, BA34G022, Exp. 09/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pantoprazole: every company that makes it
- Form
- tablet, delayed release
- Strength
- 20 mg
- Approval
- ANDA ANDA090074
- On the market since
- May 1, 2019
- Package NDCs
61919-806-3061919-806-60- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2019
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