INVOKAMET

Product NDC: 50458-543
Requested package NDC: 50458-543-60
11-digit product format: 504580543
Labeler code: 50458
Product ID: 50458-543_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; 1000 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

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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204353-001	NPP	2027-12-18
N204353-001	PED	2028-06-18
N204353-002	NPP	2027-12-18
N204353-002	PED	2028-06-18
N204353-003	NPP	2027-12-18
N204353-003	PED	2028-06-18
N204353-004	NPP	2027-12-18
N204353-004	PED	2028-06-18

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N204353-001	NPP	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-001	PED	2028-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-002	NPP	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-002	PED	2028-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-003	NPP	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-003	PED	2028-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-004	NPP	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204353-004	PED	2028-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204353-001	NPP	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-001	PED	2028-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-002	NPP	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-002	PED	2028-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-003	NPP	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-003	PED	2028-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-004	NPP	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204353-004	PED	2028-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204353-001	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	PED	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-001	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-001	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-002	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-002	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-003	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-003	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-004	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-004	PED	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204353-001	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-001	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-002	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-002	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-003	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-003	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-004	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-004	PED	2028-06-18	`6a471c1ec25d…`

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	1000 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1545150	Internal RxNorm lookup
1545156	Internal RxNorm lookup
1545157	Internal RxNorm lookup
1545159	Internal RxNorm lookup
1545161	Internal RxNorm lookup
1545163	Internal RxNorm lookup
1545164	Internal RxNorm lookup
1545166	Internal RxNorm lookup
1810997	Internal RxNorm lookup
1810999	Internal RxNorm lookup
1811002	Internal RxNorm lookup
1811003	Internal RxNorm lookup
1811006	Internal RxNorm lookup
1811007	Internal RxNorm lookup
1811010	Internal RxNorm lookup
1811011	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6868666b-c25e-40d1-9d1f-306bbe9390c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
bfd158f9-2ca9-be9c-cd97-e30d4086e4ad	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50458-543-60	INVOKAMET	60 in 1 BOTTLE	TABLET, FILM COATED	60		31
50458-543-91	INVOKAMET	10 in 1 BOTTLE	TABLET, FILM COATED	10		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-543-60	EA - Each	50458-543	2c50c6b2-e6bc-4f58-898f-f554217a9af8	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
50458-543	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 (package): 50458-543-60 ndc (product): 50458-543 ndc11 (package): 50458054360

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0SAC974Z85	CANAGLIFLOZIN	928672-86-0	CANAGLIFLOZIN
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1810997	canagliflozin 150 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545150	canagliflozin 150 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811002	canagliflozin 150 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545157	canagliflozin 150 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811006	canagliflozin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545161	canagliflozin 50 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811010	canagliflozin 50 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545164	canagliflozin 50 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545156	Invokamet 150 MG / 1000 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545159	Invokamet 150 MG / 500 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545163	Invokamet 50 MG / 1000 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545166	Invokamet 50 MG / 500 MG Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1810999	Invokamet XR 150 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811003	Invokamet XR 150 MG / 500 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811007	Invokamet XR 50 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811011	Invokamet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet	PSN	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1810999	24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811003	24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811007	24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811011	24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545156	canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545159	canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545163	canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545166	canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]	SBD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1810997	24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811002	24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811006	24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811010	24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545150	canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545157	canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545161	canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545164	canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1810997	canagliflozin 150 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811002	canagliflozin 150 MG / metformin hydrochloride 500 MG 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811006	canagliflozin 50 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811010	canagliflozin 50 MG / metformin hydrochloride 500 MG 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811007	IInvokamet (canagliflozin 50 MG / metformin hydrochloride 1000 MG) 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811011	IInvokamet (canagliflozin 50 MG / metformin hydrochloride 500 MG) 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1810999	Invokamet (canagliflozin 150 MG / metformin hydrochloride 1000 MG) 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545156	Invokamet (canagliflozin 150 MG / metformin hydrochloride 1000 MG) Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1811003	Invokamet (canagliflozin 150 MG / metformin hydrochloride 500 MG) 24HR Extended Release Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545159	Invokamet (canagliflozin 150 MG / metformin hydrochloride 500 MG) Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545163	Invokamet (canagliflozin 50 MG / metformin hydrochloride 1000 MG) Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31
1545166	Invokamet (canagliflozin 50 MG / metformin hydrochloride 500 MG) Oral Tablet	SY	6868666b-c25e-40d1-9d1f-306bbe9390c1	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-543-60	50458054360	60 TABLET, FILM COATED in 1 BOTTLE (50458-543-60)	2014-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INVOKAMET	Janssen Pharmaceuticals, Inc. \| Janssen Pharmaceuticals Inc \| Patheon Puerto Rico, Inc. \| PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH \| Janssen Pharmaceutica NV \| Ajinomoto OmniChem \| Farmhispania \| Rolabo Outsourcing S.L. (Spain) \| Janssen Cilag SpA \| Johnson & Johnson Private Limited (Mumbai) \| Janssen Ortho LLC \| Granules India Limited	2026-08-24	HUMAN PRESCRIPTION DRUG LABEL	32
INVOKAMET	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	2