INVOKAMET

Product NDC: 63629-8260
11-digit product format: 636298260
Labeler code: 63629
Product ID: 63629-8260_9cc85ffa-49f4-4612-9d7a-c3d3449179a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: canagliflozin and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA204353
Marketing category: NDA
Marketing start: 2014-08-08
Marketing end: 0000-00-00
Substance: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength: 150 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-8260		D	Discontinued by firm	2026-08-10
excluded package	package	63629-8260	63629-8260-1	D	Discontinued by firm	2026-08-10
excluded package	package	63629-8260	63629-8260-2	D	Discontinued by firm	2026-08-10

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-8260-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-8260-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-8260-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-8260-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-8260-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-8260-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-8260-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-8260-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-8260-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-8260-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-8260-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-8260-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-8260-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-8260-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-8260-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-8260-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-8260-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-8260-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-8260-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-8260-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-8260-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-8260-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-8260-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-8260-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,904 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204353-001	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-001	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-001	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-002	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-002	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-003	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-003	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-004	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-004	PED	2028-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-001	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-001	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-002	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-002	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-003	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-003	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-004	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-004	PED	2028-06-18	`b8a1b40f171c…`

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	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204353 application number: NDA204353

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8260-1	63629826001	30 TABLET, FILM COATED in 1 BOTTLE (63629-8260-1)	2014-08-08	0000-00-00	No	No	Current
63629-8260-2	63629826002	60 TABLET, FILM COATED in 1 BOTTLE (63629-8260-2)	2014-08-08	0000-00-00	No	No	Current