NDC 0615-8533
Rosuvastatin Calcium 10 mg tablet, film coated
On the label: NCS HealthCare of KY, Inc dba Vangard Labs. It's repackaged: NCS HealthCare of KY, Inc dba Vangard Labs rebottles it from Aurobindo Pharma Limited's NDC 65862-294.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it and tests 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
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Product details
- Generic drug
- Rosuvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA079170
- On the market since
- Jul 19, 2016
- Package NDCs
0615-8533-39- Official label
- DailyMed (National Library of Medicine), updated Sep 27, 2024
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