NDC 69097-527
Esomeprazole Magnesium 10 mg granule, for suspension, extended release
On the label: Cipla USA., Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Pune, India | Makes it and makes the active ingredient | Problems found, fixed voluntarilyMay 8, 2024 · 7 inspections |
| Cipla Limited | Bengaluru, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 13, 2024 · 7 inspections |
Recalls
- Dec 17, 2020 · Class II · Cipla
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Lots: Lot #: KA00411, KA00412, KA00460, Exp 11/2021
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
- granule, for suspension, extended release, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA211752
- On the market since
- Mar 24, 2020
- Package NDCs
69097-527-34- Official label
- DailyMed (National Library of Medicine), updated May 16, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?