NDC 63304-735
Esomeprazole magnesium 40 mg capsule, delayed release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's 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 |
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, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA209735
- On the market since
- Sep 18, 2025
- Package NDCs
63304-735-1063304-735-3063304-735-90- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2025
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