NDC 50458-940
Invokamet XR 50 mg / 500 mg tablet, film coated, extended release
On the label: Janssen Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Farmhispania S.A. | Montmelo, Spain | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 12, 2023 · 5 inspections |
| Janssen Ortho LLC | Gurabo, PR, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Janssen Pharmaceutica NV | Geel, Belgium | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections |
| Patheon Puerto Rico, Inc. | Manati, PR, United States | Makes it | Problems found, fixed voluntarilyJul 12, 2022 · 9 inspections |
| Rolabo Outsourcing S.L. | Zaragoza, Spain | Makes the active ingredient | Problems found, fixed voluntarilyDec 21, 2023 · 6 inspections |
| Eurofins PHAST GmbH | Homburg, Germany | Tests it | Problems found, fixed voluntarilyDec 13, 2023 · 4 inspections |
| Janssen Pharmaceutica NV | Beerse, Belgium | Tests it | Problems found, fixed voluntarilySep 5, 2025 · 8 inspections |
| Janssen Pharmaceuticals, Inc. | Titusville, NJ, United States | Tests it | Problems found, fixed voluntarilySep 25, 2026 · 11 inspections |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
Recalls
- Oct 19, 2016 · Class III · Janssen Ortho L.L.C.
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Lots: Lot #: 16GG581X, Exp 09/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Canagliflozin and Metformin: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 50 mg / 500 mg
- Approval
- NDA NDA205879
- On the market since
- Sep 20, 2016
- Package NDCs
50458-940-0150458-940-02- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2026
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