Tecfidera

Product NDC: 64406-007
Requested package NDC: 64406-007-03
11-digit product format: 644060007
Labeler code: 64406
Product ID: 64406-007_521e4305-9450-42a4-881b-05946acaa8fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dimethyl fumarate
Dosage form: KIT
Labeler: Biogen Inc.
Application: NDA204063
Marketing category: NDA
Marketing start: 2013-03-27
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 640 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10959972	2035-11-16	U-1384	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11007166	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11007167	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11129806	2035-11-16	U-1384	2021-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11246850	2035-11-16	U-1384	2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	8399514	2028-02-07	U-1384	2013-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10391160	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10555993	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10994003	2035-03-13	U-3148	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10959972	2035-11-16	U-1384	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11007166	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11007167	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11129806	2035-11-16	U-1384	2021-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11246850	2035-11-16	U-1384	2022-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`6a471c1ec25d…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tecfidera
Listing expiration: 2026-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FO2303MNI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373483	Internal RxNorm lookup
1373489	Internal RxNorm lookup
1373491	Internal RxNorm lookup
1373493	Internal RxNorm lookup
1373497	Internal RxNorm lookup
1373498	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
665d7e74-036c-5f68-5b67-ab84b9b49151	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
782c9b32-f61c-48d7-9845-328403da8b33	Product name	5	20250303
81073386-7d67-4d1d-80dd-72b360506a77	Product name	1	20200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64406-007-03	Tecfidera	1 in 1 KIT	KIT	1		55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-007-03	EA - Each	64406-007	2249386f-6a3f-4f7c-a5aa-43018296fa92	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dimethyl fumarate	ACTIVE INGREDIENT	FO2303MNI2	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
monomethyl fumarate	ACTIVE MOIETY	45IUB1PX8R	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Gelatin	INACTIVE INGREDIENT	2G86QN327L	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)	INACTIVE INGREDIENT	74G4R6TH13	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32
Triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-007	TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]	54	Current NDC, Legacy NDC, 1 package rows	20240319_665d7e74-036c-5f68-5b67-ab84b9b49151.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
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 ndc (package): 64406-007-03 ndc (product): 64406-007 ndc11 (package): 64406000703

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373498	{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule [Tecfidera]) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule [Tecfidera]) } Pack [Tecfidera 30-Day Starter Pack]	BPCK	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373497	{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } Pack	GPCK	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373497	dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373489	Tecfidera 120 MG Delayed Release Oral Capsule	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373493	Tecfidera 240 MG Delayed Release Oral Capsule	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373498	Tecfidera 30-Day Starter Pack	PSN	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373489	dimethyl fumarate 120 MG Delayed Release Oral Capsule [Tecfidera]	SBD	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373493	dimethyl fumarate 240 MG Delayed Release Oral Capsule [Tecfidera]	SBD	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373493	Tecfidera (dimethyl fumarate 240 MG) Delayed Release Oral Capsule	SY	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373489	Tecfidera 120 MG Delayed Release Oral Capsule	SY	665d7e74-036c-5f68-5b67-ab84b9b49151	55
1373493	Tecfidera 240 MG Delayed Release Oral Capsule	SY	665d7e74-036c-5f68-5b67-ab84b9b49151	55

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-007-03	64406000703	1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC	1 kit	2013-03-27	0000-00-00	No	No	Current