NDC 50458-541
Invokamet 50 mg / 1000 mg tablet, film coated
On the label: Janssen Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ajinomoto Omnichem | Wetteren, Belgium | Makes the active ingredient | Problems found, fixed voluntarilyJun 13, 2025 · 5 inspections |
| Farmhispania S.A. | Montmelo, Spain | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 12, 2023 · 5 inspections |
| Granules India Limited | Medchal-Malkajgiri District, India | Makes the active ingredient and tests it | No problems foundJun 23, 2023 · 5 inspections |
| Janssen Cilag SpA | Borgo San Michele, Italy | Makes it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Janssen Ortho LLC | Gurabo, PR, United States | Makes 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 |
| 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 |
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, oral
- Strength
- 50 mg / 1000 mg
- Approval
- NDA NDA204353
- On the market since
- Aug 8, 2014
- Package NDCs
50458-541-6050458-541-91- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2026
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