NDC 67046-525
Olanzapine 10 mg tablet, film coated
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-070.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Aug 27, 2026 · Class III · Macleods Pharmaceuticals Limited
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Lots: Lot: BOB22321A, Exp 07-31-2027. - Nov 25, 2024 · Class II · Macleods Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications
Lots: Lot# BOB12318A Exp 07/31/2027 - Feb 16, 2022 · Class II · Macleods Pharma Usa Inc
cGmp Deviations
Lots: Lot #: BOB42029A, BOB4202B, Exp. Date 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
- Olanzapine: every company that makes it
- Form
- tablet, film coated
- Strength
- 10 mg
- Approval
- ANDA ANDA202862
- On the market since
- Oct 4, 2017
- Package NDCs
67046-525-0767046-525-1467046-525-1567046-525-2067046-525-2167046-525-2867046-525-3067046-525-60- Official label
- DailyMed (National Library of Medicine), updated Oct 4, 2017
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