Home NDC 50458-542 INVOKAMET
Product NDC 50458-542
11-digit product format 504580542
Labeler code 50458
Product ID 50458-542_95b8c81c-dfe3-4dd4-be06-8dd1d935f07e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name canagliflozin and metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA204353
Marketing category NDA
Marketing start 2014-08-08
Substance CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength 150; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204353-001 INVOKAMET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50MG;500MG TABLET / ORAL RLD 2014-08-08 N204353-002 INVOKAMET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50MG;1GM TABLET / ORAL RLD 2014-08-08 N204353-003 INVOKAMET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150MG;500MG TABLET / ORAL RLD 2014-08-08 N204353-004 INVOKAMET CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08
Orange Book patents# Current patent rows page 1 of 1 · 44 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204353-001 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 N204353-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 N204353-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 N204353-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 N204353-001 7943788*PED 2028-01-14 Pediatric extension N204353-001 8513202*PED 2028-06-03 Pediatric extension N204353-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 N204353-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 N204353-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 N204353-001 7943582*PED 2029-08-26 Pediatric extension N204353-001 11576894 2030-07-06 Drug product 2023-03-13 N204353-002 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 N204353-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 N204353-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 N204353-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 N204353-002 7943788*PED 2028-01-14 Pediatric extension N204353-002 8513202*PED 2028-06-03 Pediatric extension N204353-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 N204353-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 N204353-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 N204353-002 7943582*PED 2029-08-26 Pediatric extension N204353-002 11576894 2030-07-06 Drug product 2023-03-13 N204353-003 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 N204353-003 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 N204353-003 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 N204353-003 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 N204353-003 7943788*PED 2028-01-14 Pediatric extension N204353-003 8513202*PED 2028-06-03 Pediatric extension N204353-003 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 N204353-003 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 N204353-003 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 N204353-003 7943582*PED 2029-08-26 Pediatric extension N204353-003 11576894 2030-07-06 Drug product 2023-03-13 N204353-004 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 N204353-004 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 N204353-004 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 N204353-004 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 N204353-004 7943788*PED 2028-01-14 Pediatric extension N204353-004 8513202*PED 2028-06-03 Pediatric extension N204353-004 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 N204353-004 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 N204353-004 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 N204353-004 7943582*PED 2029-08-26 Pediatric extension N204353-004 11576894 2030-07-06 Drug product 2023-03-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204353-001 INVOKAMET 50MG;500MG TABLET / ORAL RLD 2014-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204353-002 INVOKAMET 50MG;1GM TABLET / ORAL RLD 2014-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204353-003 INVOKAMET 150MG;500MG TABLET / ORAL RLD 2014-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204353-004 INVOKAMET 150MG;1GM TABLET / ORAL RLD, RS 2014-08-08 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 50 · 1,992 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204353-001 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 7943582*PED 2029-08-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-001 11576894 2030-07-06 Drug product 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 7943582*PED 2029-08-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-002 11576894 2030-07-06 Drug product 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943582 2029-02-26 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943582 2029-02-26 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 7943582*PED 2029-08-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-003 11576894 2030-07-06 Drug product 2023-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 7943788 2027-07-14 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 8513202 2027-12-03 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 8513202 2027-12-03 U-2441 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 8513202 2027-12-03 U-2632 Drug substance, Drug product 2014-09-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204353-004 7943582 2029-02-26 U-493 Drug substance, Drug product 2014-09-04 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base INVOKAMET
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANAGLIFLOZIN 150 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup 0SAC974Z85 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 16 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-542-60 INVOKAMET 60 in 1 BOTTLE TABLET, FILM COATED 60 31 50458-542-91 INVOKAMET 10 in 1 BOTTLE TABLET, FILM COATED 10 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded canagliflozin ACTIVE INGREDIENT 0SAC974Z85 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 metformin hydrochloride ACTIVE INGREDIENT 786Z46389E INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 canagliflozin anhydrous ACTIVE MOIETY 6S49DGR869 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 metformin ACTIVE MOIETY 9100L32L2N INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 talc INACTIVE INGREDIENT 7SEV7J4R1U INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-542 INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 30 Current NDC, Legacy NDC, 2 package rows 20250101_6868666b-c25e-40d1-9d1f-306bbe9390c1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INVOKAMET CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Janssen Pharmaceuticals, Inc. 6868666b-c25e-40d1-9d1f-306bbe9390c1 2026-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204353 application number: NDA204353 ndc (product): 50458-542
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50458-542-60 50458054260 60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) 2014-08-08 0000-00-00 No No Current 50458-542-91 50458054291 10 in 1 BOTTLE Historical