NDC 71335-2011
Esomeprazole magnesium 40 mg capsule, delayed release
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 63304-735.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ohm Laboratories Inc. | New Brunswick, NJ, United States | Makes it | No problems foundOct 31, 2024 · 22 inspections |
| Sun Pharmaceutical Industries Limited | Bharuch, India | Makes the active ingredient | No problems foundJun 13, 2025 · 6 inspections |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Jun 21, 2022 · Class III · Sun Pharmaceutical Industries Inc
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Lots: Lot AC14299, Exp 12/2022 - Jun 21, 2022 · Class III · Sun Pharmaceutical Industries Inc
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Lots: Lot AC14304, Exp 12/2022.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Esomeprazole: every company that makes it
- Form
- capsule, delayed release
- Strength
- 40 mg
- Approval
- ANDA ANDA209735
- On the market since
- May 31, 2018
- Package NDCs
71335-2011-171335-2011-271335-2011-371335-2011-471335-2011-571335-2011-671335-2011-7- Official label
- DailyMed (National Library of Medicine), updated May 23, 2024
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