NDC 43353-614
Mirtazapine 45 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Aurolife Pharma LLC's NDC 13107-032.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Packages it and labels it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 031180028A, Exp. Date 03/2021 - Nov 20, 2019 · Class I · AuroMedics Pharma LLC
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Lots: Lot #: 03119002A3, Exp 3/2022 - Nov 20, 2019 · Class I · AuroMedics Pharma LLC
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Lots: Lot #: 03119002A3, Exp 3/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mirtazapine: every company that makes it
- Form
- tablet, film coated
- Strength
- 45 mg
- Approval
- ANDA ANDA076921
- On the market since
- Aug 17, 2009
- Package NDCs
43353-614-30- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2019
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