INVOKANA

Product NDC: 50090-5033
11-digit product format: 500905033
Labeler code: 50090
Product ID: 50090-5033_efb00e24-451f-4476-bd47-c2e7bdcfbf45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: canagliflozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA204042
Marketing category: NDA
Marketing start: 2013-03-29
Marketing end: 0000-00-00
Substance: CANAGLIFLOZIN
Active strength: 100 mg/1
Pharmacologic classes: 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	50090-5033		D	Discontinued by firm	2026-08-07
excluded package	package	50090-5033	50090-5033-0	D	Discontinued by firm	2026-08-07
excluded package	package	50090-5033	50090-5033-1	D	Discontinued by firm	2026-08-07

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 · 21 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	50090-5033-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5033-1	`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	50090-5033-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5033-1	`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	50090-5033-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5033-1	`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	50090-5033-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5033-1	`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	50090-5033-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5033-1	`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	50090-5033-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5033-1	`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	50090-5033-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5033-1	`302b2466d912…`	`e7b80fea0513…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204042-001	INVOKANA	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB	RLD	2013-03-29
N204042-002	INVOKANA	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB	RLD, RS	2013-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N204042-001	AB
N204042-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16
N204042-001	7943788*PED	2028-01-14		Pediatric extension
N204042-001	8513202*PED	2028-06-03		Pediatric extension
N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16
N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16
N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16
N204042-001	7943582*PED	2029-08-26		Pediatric extension
N204042-002	7943788	2027-07-14		Drug substance, Drug product
N204042-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16
N204042-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16
N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16
N204042-002	7943788*PED	2028-01-14		Pediatric extension
N204042-002	8513202*PED	2028-06-03		Pediatric extension
N204042-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16
N204042-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16
N204042-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16
N204042-002	7943582*PED	2029-08-26		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204042-001	NPP	2027-12-18
N204042-001	PED	2028-06-18
N204042-002	NPP	2027-12-18
N204042-002	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 3 · 82 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	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204042-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204042-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,428 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	N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943788	2027-07-14		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-493		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-2441		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-2632		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219*PED	2025-10-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943788*PED	2028-01-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202*PED	2028-06-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582*PED	2029-08-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-493		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-2632		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-2441		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219*PED	2025-10-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	7943788	2027-07-14		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 94 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	N204042-001	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	PED	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	PED	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204042-001	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-001	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	PED	2028-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	PED	2028-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	PED	2028-06-18	`b8a1b40f171c…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-001	I-809	2022-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-002	I-809	2022-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204042-001	I-809	2022-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204042-002	I-809	2022-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204042-001	I-809	2022-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204042-002	I-809	2022-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-733	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	M-197	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-788	2021-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-809	2022-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-733	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	M-197	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-788	2021-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-809	2022-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204042-001	I-809	2022-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204042-002	I-809	2022-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204042-001	I-788	2021-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-001	I-809	2022-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	I-788	2021-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	I-809	2022-09-27	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5033-0	EA - Each	50090-5033	d057b765-4ce1-4d67-83c4-d3780bbb1ba9	1	2023-01-09
50090-5033-1	EA - Each	50090-5033	1680cb1d-d9e5-443c-a6a7-d360fc7a7e06	1	2022-12-07

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INVOKANA	CANAGLIFLOZIN	Janssen Pharmaceuticals, Inc.	b9057d3b-b104-4f09-8a61-c61ef9d4a3f3	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042
INVOKANA	CANAGLIFLOZIN	Cardinal Health 107, LLC	5f76e16f-0c24-454a-81af-4080b312c940	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	9679460c-55f7-4826-b55c-fe116f020358	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	8d5f892b-e4f3-4a9e-9a91-95e2fca34144	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0SAC974Z85	CANAGLIFLOZIN	928672-86-0	CANAGLIFLOZIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5033-0	50090503300	90 TABLET, FILM COATED in 1 BOTTLE (50090-5033-0)	2020-05-01	0000-00-00	No	No	Current
50090-5033-1	50090503301	30 TABLET, FILM COATED in 1 BOTTLE (50090-5033-1)	2020-05-05	0000-00-00	No	No	Current