Quick answers
- What is Canagliflozin and metformin hydrochloride used for?
- The FDA-approved label (Invokamet, Janssen Pharmaceuticals, Inc., August 24, 2026) says: “INVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Canagliflozin and metformin hydrochloride have a boxed warning?
- Yes. The FDA label for Invokamet has a boxed warning (“WARNING: LACTIC ACIDOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Canagliflozin and metformin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Canagliflozin and metformin hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 19, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Canagliflozin and metformin hydrochloride?
- 1 company lists prescription products of Canagliflozin and metformin hydrochloride in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc..
What Canagliflozin and metformin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. …
— FDA label: Invokamet, Janssen Pharmaceuticals, Inc., effective August 24, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LACTIC ACIDOSIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Invokamet, Invokamet XR |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| canagliflozin 150 mg · metformin hydrochloride 1000 mg tablet, film coated | Brand: Invokamet | $9.55 per tablet |
| canagliflozin 150 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release | Brand: Invokamet XR | $9.52 per tablet |
| canagliflozin 150 mg · metformin hydrochloride 500 mg tablet, film coated | Brand: Invokamet | $9.60 per tablet |
| canagliflozin 150 mg · metformin hydrochloride 500 mg tablet, film coated, extended release | Brand: Invokamet XR | $9.56 per tablet |
| canagliflozin 50 mg · metformin hydrochloride 1000 mg tablet, film coated | Brand: Invokamet | $9.54 per tablet |
| canagliflozin 50 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release | Brand: Invokamet XR | $9.69 per tablet |
| canagliflozin 50 mg · metformin hydrochloride 500 mg tablet, film coated | Brand: Invokamet | $9.56 per tablet |
| canagliflozin 50 mg · metformin hydrochloride 500 mg tablet, film coated, extended release | Brand: Invokamet XR | $9.68 per tablet |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Pharmaceuticals, Inc.8 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204353 INVOKAMET | Janssen Pharms | August 8, 2014 | 27, latest August 11, 2026 2026: Labeling · 2026: Labeling · 2024: Efficacy |
| NDA205879 INVOKAMET XR | Janssen Pharms | September 20, 2016 | 15, latest August 11, 2026 2026: Labeling · 2026: Labeling · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 19, 2016 · Class III · Terminated · D-0115-2017
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.
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titu — Janssen Ortho L.L.C.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Invokamet, Janssen Pharmaceuticals, Inc., effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →