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INVOKAMET

canagliflozin and metformin hydrochloride · Tablet, Film Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
INVOKAMET
Generic name
canagliflozin and metformin hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Janssen Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
55% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Canagliflozin 150 mg/1 1545150 View
Canagliflozin 50 mg/1 1545150 View
Metformin Hydrochloride 1000 mg/1 860975 View
Metformin Hydrochloride 500 mg/1 860975 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Biguanide [EPC] EPC All 47 members
Biguanides [CS] CS All 47 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Sodium-Glucose Cotransporter 2 Inhibitor [EPC] EPC All 16 members
Sodium-Glucose Transporter 2 Inhibitors [MoA] MoA All 16 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
204353
Application type
NDA · New Drug Application
Approval date
August 8, 2014
Sponsor
JANSSEN PHARMS
Products on application
4
Submissions recorded
29
Products approved under application 204353.
Product Trade name Form Strength Ingredient Status TE Flags
204353-001 INVOKAMET TABLET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription — RLD
204353-002 INVOKAMET TABLET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription — RLD
204353-003 INVOKAMET TABLET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription — RLD
204353-004 INVOKAMET TABLET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7943788 July 14, 2027 001 Yes September 4, 2014
7943788 July 14, 2027 002 Yes September 4, 2014
7943788 July 14, 2027 003 Yes September 4, 2014
7943788 July 14, 2027 004 Yes September 4, 2014
8513202 December 3, 2027 001 Yes U-2441 September 4, 2014
8513202 December 3, 2027 001 Yes U-2632 September 4, 2014
8513202 December 3, 2027 001 Yes U-493 September 4, 2014
8513202 December 3, 2027 002 Yes U-493 September 4, 2014
8513202 December 3, 2027 002 Yes U-2632 September 4, 2014
8513202 December 3, 2027 002 Yes U-2441 September 4, 2014
8513202 December 3, 2027 003 Yes U-493 September 4, 2014
8513202 December 3, 2027 003 Yes U-2632 September 4, 2014
8513202 December 3, 2027 003 Yes U-2441 September 4, 2014
8513202 December 3, 2027 004 Yes U-493 September 4, 2014
8513202 December 3, 2027 004 Yes U-2441 September 4, 2014
8513202 December 3, 2027 004 Yes U-2632 September 4, 2014
7943788*PED January 14, 2028 001 No —
7943788*PED January 14, 2028 002 No —
7943788*PED January 14, 2028 003 No —
7943788*PED January 14, 2028 004 No —
8513202*PED June 3, 2028 001 No —
8513202*PED June 3, 2028 002 No —
8513202*PED June 3, 2028 003 No —
8513202*PED June 3, 2028 004 No —
7943582 February 26, 2029 001 Yes U-493 September 4, 2014
7943582 February 26, 2029 001 Yes U-2441 September 4, 2014
7943582 February 26, 2029 001 Yes U-2632 September 4, 2014
7943582 February 26, 2029 002 Yes U-2441 September 4, 2014
7943582 February 26, 2029 002 Yes U-2632 September 4, 2014
7943582 February 26, 2029 002 Yes U-493 September 4, 2014
7943582 February 26, 2029 003 Yes U-493 September 4, 2014
7943582 February 26, 2029 003 Yes U-2632 September 4, 2014
7943582 February 26, 2029 003 Yes U-2441 September 4, 2014
7943582 February 26, 2029 004 Yes U-493 September 4, 2014
7943582 February 26, 2029 004 Yes U-2632 September 4, 2014
7943582 February 26, 2029 004 Yes U-2441 September 4, 2014
7943582*PED August 26, 2029 001 No —
7943582*PED August 26, 2029 002 No —
7943582*PED August 26, 2029 003 No —
7943582*PED August 26, 2029 004 No —
11576894 July 6, 2030 001 No March 13, 2023
11576894 July 6, 2030 002 No March 13, 2023
11576894 July 6, 2030 003 No March 13, 2023
11576894 July 6, 2030 004 No March 13, 2023
Regulatory exclusivity periods.
Code Expires Product
NPP December 18, 2027 001
NPP December 18, 2027 002
NPP December 18, 2027 003
NPP December 18, 2027 004
PED June 18, 2028 001
PED June 18, 2028 002
PED June 18, 2028 003
PED June 18, 2028 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 204353.
Type No. Action Status Date Review
Supplement 49 Labeling Approved August 11, 2026 901 Required
Supplement 48 Labeling Approved August 11, 2026 Standard
Supplement 46 Efficacy Approved December 18, 2024 Priority
Supplement 45 Labeling Approved August 23, 2024 Standard
Supplement 43 Labeling Approved January 19, 2024 Standard
Supplement 42 Labeling Approved July 5, 2023 Standard
Supplement 41 Labeling Approved October 13, 2022 901 Required
Supplement 39 Efficacy Approved August 18, 2020 Standard
Supplement 33 Efficacy Approved January 27, 2020 Standard
Supplement 36 Labeling Approved January 24, 2020 901 Required
Supplement 25 Efficacy Approved October 29, 2018 Standard
Supplement 31 Labeling Approved October 26, 2018 901 Required
Supplement 24 Labeling Approved August 11, 2017 Standard
Supplement 23 Labeling Approved July 25, 2017 901 Required
Supplement 14 Efficacy Approved February 1, 2017 Standard
Supplement 19 Manufacturing (CMC) Approved November 23, 2016 Standard
Supplement 20 Labeling Approved August 17, 2016 901 Required
Supplement 15 Labeling Approved May 20, 2016 901 Required
Supplement 6 Efficacy Approved May 20, 2016 Standard
Supplement 11 Manufacturing (CMC) Approved April 14, 2016 Standard
Supplement 10 Labeling Approved March 28, 2016 Standard
Supplement 8 Manufacturing (CMC) Approved March 17, 2016 Standard
Supplement 7 Manufacturing (CMC) Approved December 23, 2015 Standard
Supplement 12 Labeling Approved December 4, 2015 901 Required
Supplement 3 Efficacy Approved September 10, 2015 Standard
Supplement 4 Manufacturing (CMC) Approved June 8, 2015 Standard
Supplement 2 Labeling Approved March 3, 2015 Standard
Original application 1 Type 4 - New Combination Approved August 8, 2014 Standard
Supplement 38 Labeling Approved — 901 Required

Review documents

  • 0 · Supplement · August 19, 2026
  • 0 · Supplement · August 18, 2026
  • 0 · Supplement · August 18, 2026
  • 0 · Supplement · August 18, 2026
  • 0 · Supplement · August 14, 2026
  • 0 · Supplement · August 14, 2026
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · August 26, 2024
  • 0 · Supplement · August 26, 2024
  • 0 · Supplement · January 23, 2024
  • 0 · Supplement · January 22, 2024
  • 0 · Supplement · July 7, 2023
  • 0 · Supplement · July 6, 2023
  • 0 · Supplement · October 17, 2022
  • 0 · Supplement · October 14, 2022
  • 0 · Supplement · August 19, 2020
  • 0 · Supplement · August 19, 2020
  • 0 · Supplement · January 28, 2020
  • 0 · Supplement · January 28, 2020
  • 0 · Supplement · January 27, 2020
  • 0 · Supplement · January 27, 2020
  • 0 · Supplement · October 31, 2018
  • 0 · Supplement · October 31, 2018
  • 0 · Supplement · October 30, 2018
  • 0 · Supplement · October 30, 2018
  • 0 · Supplement · August 21, 2017
  • 0 · Supplement · August 14, 2017
  • 0 · Supplement · July 28, 2017
  • 0 · Supplement · July 25, 2017

Adverse event reports

Source: openFDA FAERS
91,381
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: METFORMIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III November 2, 2016 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. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50458-540-60 50458-540 Janssen Pharmaceuticals, Inc. 60 TABLET, FILM COATED in 1 BOTTLE (50458-540-60) August 8, 2014
50458-541-60 50458-541 Janssen Pharmaceuticals, Inc. 60 TABLET, FILM COATED in 1 BOTTLE (50458-541-60) August 8, 2014
50458-542-60 50458-542 Janssen Pharmaceuticals, Inc. 60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) August 8, 2014
50458-543-60 50458-543 Janssen Pharmaceuticals, Inc. 60 TABLET, FILM COATED in 1 BOTTLE (50458-543-60) August 8, 2014
50458-540 50458-540 Janssen Pharmaceuticals, Inc. — August 8, 2014
50458-541 50458-541 Janssen Pharmaceuticals, Inc. — August 8, 2014
50458-542 50458-542 Janssen Pharmaceuticals, Inc. — August 8, 2014
50458-543 50458-543 Janssen Pharmaceuticals, Inc. — August 8, 2014

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.