dimethyl fumarate

Product NDC: 0093-9219
Requested package NDC: 0093-9219-06
11-digit product format: 000939219
Labeler code: 0093
Product ID: 0093-9219_0b2673ca-4000-4697-ad2b-c36b7524e1f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dimethyl fumarate
Dosage form: CAPSULE
Route: ORAL
Labeler: TEVA PHARMACEUTICALS USA, INC.
Application: NDA204063
Marketing category: NDA
Marketing start: 2020-09-28
Marketing end: 2024-04-30
Substance: DIMETHYL FUMARATE
Active strength: 240 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0093-9219	0093-9219-06	D	Discontinued by firm		2026-08-17

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 42.

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
N204063-001	TECFIDERA	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27
N204063-002	TECFIDERA	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204063-001	AB
N204063-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N204063-001	8399514	2028-02-07	U-1384	2013-04-24
N204063-001	10391160	2035-03-13	U-3148	2021-04-28
N204063-001	10555993	2035-03-13	U-3148	2021-04-28
N204063-001	10994003	2035-03-13	U-3148	2021-05-28
N204063-001	10959972	2035-11-16	U-1384	2021-04-28
N204063-001	11007166	2035-11-16	U-1384	2021-05-28
N204063-001	11007167	2035-11-16	U-1384	2021-05-28
N204063-001	11129806	2035-11-16	U-1384	2021-10-27
N204063-001	11246850	2035-11-16	U-1384	2022-03-11
N204063-002	8399514	2028-02-07	U-1384	2013-04-24
N204063-002	10391160	2035-03-13	U-3148	2021-04-28
N204063-002	10555993	2035-03-13	U-3148	2021-04-28
N204063-002	10994003	2035-03-13	U-3148	2021-05-28
N204063-002	10959972	2035-11-16	U-1384	2021-04-28
N204063-002	11007166	2035-11-16	U-1384	2021-05-28
N204063-002	11007167	2035-11-16	U-1384	2021-05-28
N204063-002	11129806	2035-11-16	U-1384	2021-10-27
N204063-002	11246850	2035-11-16	U-1384	2022-03-11

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 · 84 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
2026-08-18 06:07:40	2026-07	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2013-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N204063-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204063-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204063-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204063-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204063-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204063-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204063-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 658 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	10959972	2035-11-16	U-1384	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	11007166	2035-11-16	U-1384	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	11007167	2035-11-16	U-1384	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	11129806	2035-11-16	U-1384	2021-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-001	11246850	2035-11-16	U-1384	2022-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	8399514	2028-02-07	U-1384	2013-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	10391160	2035-03-13	U-3148	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	10555993	2035-03-13	U-3148	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	10994003	2035-03-13	U-3148	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	10959972	2035-11-16	U-1384	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	11007166	2035-11-16	U-1384	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	11007167	2035-11-16	U-1384	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	11129806	2035-11-16	U-1384	2021-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204063-002	11246850	2035-11-16	U-1384	2022-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10959972	2035-11-16	U-1384	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11007166	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11007167	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11129806	2035-11-16	U-1384	2021-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11246850	2035-11-16	U-1384	2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	8399514	2028-02-07	U-1384	2013-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10391160	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10555993	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10994003	2035-03-13	U-3148	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10959972	2035-11-16	U-1384	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11007166	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11007167	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11129806	2035-11-16	U-1384	2021-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11246850	2035-11-16	U-1384	2022-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	M-260	2023-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	M-260	2023-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	M-260	2023-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	M-260	2023-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	M-260	2023-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	M-260	2023-02-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204063-001	M-260	2023-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	M-260	2023-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204063-001	M-260	2023-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	M-260	2023-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-001	M-260	2023-02-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-002	M-260	2023-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204063-001	M-260	2023-02-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204063-002	M-260	2023-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204063-001	M-260	2023-02-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204063-002	M-260	2023-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204063-001	M-260	2023-02-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204063-002	M-260	2023-02-05	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N204063-001	M-260	2023-02-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204063-002	M-260	2023-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204063-001	M-260	2023-02-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204063-002	M-260	2023-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204063-001	M-260	2023-02-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204063-002	M-260	2023-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204063-001	M-260	2023-02-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204063-002	M-260	2023-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204063-001	M-260	2023-02-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204063-002	M-260	2023-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204063-001	M-260	2023-02-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N204063-002	M-260	2023-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204063-001	M-260	2023-02-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204063-002	M-260	2023-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204063-001	M-260	2023-02-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204063-002	M-260	2023-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204063-001	M-260	2023-02-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204063-002	M-260	2023-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204063-001	M-260	2023-02-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N204063-002	M-260	2023-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204063-001	M-260	2023-02-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204063-002	M-260	2023-02-05	`cb3db0bc1861…`

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
TECFIDERA	DIMETHYL FUMARATE	Biogen Inc.	665d7e74-036c-5f68-5b67-ab84b9b49151	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204063 application number: NDA204063

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FO2303MNI2	DIMETHYL FUMARATE	624-49-7	DIMETHYL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-9219-06	00093921906	1 BOTTLE, PLASTIC in 1 CARTON (0093-9219-06) > 60 CAPSULE in 1 BOTTLE, PLASTIC	2020-09-28	2024-04-30	No	No	Current