NDC 67046-008
Allopurinol 100 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. 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
- Coupler Enterprises, Location not on file · 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
- Strength
- 100 mg
- Approval
- ANDA ANDA075798
- On the market since
- Jun 27, 2003
- Package NDCs
67046-008-30- Official label
- DailyMed (National Library of Medicine), updated Aug 30, 2017
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