NDC 43353-963
Mirtazapine 15 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Mylan Pharmaceuticals Inc.'s NDC 0378-3515.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Mylan Pharmaceuticals Inc. names for other drugs.
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Jan 19, 2017 · Class II · Mylan Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Lots: a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019
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
- 15 mg
- Approval
- ANDA ANDA076122
- On the market since
- Dec 28, 2012
- Package NDCs
43353-963-1543353-963-3043353-963-60- Official label
- DailyMed (National Library of Medicine), updated Jun 21, 2016
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