NDC 0615-8385
Allopurinol 100 mg tablet
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 ENDO USA, Inc.'s NDC 0603-2115.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Makes it and tests it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
| Par Formulations Private Limited | Chennai, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 10, 2026 · 7 inspections |
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Packages it and labels it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
Repackaging site
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Recalls
- Jul 20, 2015 · Class III · Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Lots: CP0761501, Exp. 12/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Allopurinol: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA075798
- On the market since
- Jun 27, 2003
- Package NDCs
0615-8385-050615-8385-39- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2026
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