Vumerity

Product NDC: 64406-020
11-digit product format: 644060020
Labeler code: 64406
Product ID: 64406-020_25e0bcfe-8df7-4a62-9db1-ba39a266e8bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diroximel fumarate
Dosage form: CAPSULE
Route: ORAL
Labeler: Biogen Inc.
Application: NDA211855
Marketing category: NDA
Marketing start: 2019-10-29
Substance: DIROXIMEL FUMARATE
Active strength: 231 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64406-020	64406-020-01	D	Discontinued by firm		2026-08-17
excluded package	package	64406-020	64406-020-05	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 · 8 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	64406-020-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	64406-020-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	64406-020-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	64406-020-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	64406-020-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	64406-020-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	64406-020-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	64406-020-05	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211855-001	VUMERITY	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N211855-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22
N211855-001	9090558	2033-09-20	U-1384		2019-11-22
N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22

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.

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	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N211855-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211855-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211855-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIROXIMEL FUMARATE	231 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K0N0Z40J3W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2261788	Internal RxNorm lookup
2261794	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
2d74414f-6b83-4ea2-9a95-3cecabbce774	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
782c9b32-f61c-48d7-9845-328403da8b33	Product name	5	20250303
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
81073386-7d67-4d1d-80dd-72b360506a77	Product name	1	20200414
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64406-020-01	2024-08-07	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-03	2024-08-07	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-05	2024-08-07	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-07	2024-08-07	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-01	2024-07-30	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-03	2024-07-30	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-05	2024-07-30	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
64406-020-07	2024-07-30	These highlights do not include all the information needed to use VUMERITY ® safely and effectively. See full prescribing information for VUMERITY. VUMERITY ® (diroximel fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64406-020-01	Vumerity	1 in 1 CARTON	CAPSULE	1	16
64406-020-01	Vumerity	106 in 1 BOTTLE, PLASTIC	CAPSULE	106	16
64406-020-03	Vumerity	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	16
64406-020-03	Vumerity	1 in 1 CARTON	CAPSULE	1	16
64406-020-05	Vumerity	1 in 1 CARTON	CAPSULE	1	16
64406-020-05	Vumerity	106 in 1 BOTTLE, PLASTIC	CAPSULE	106	16
64406-020-07	Vumerity	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	16
64406-020-07	Vumerity	1 in 1 CARTON	CAPSULE	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-020-01	EA - Each	64406-020	f9e25515-bd78-4ae5-af07-9d98a07ffc57	1	2019-12-10
64406-020-03	EA - Each	64406-020	584752e0-9497-404b-b4e8-458af39719c6	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-020	VUMERITY (DIROXIMEL FUMARATE) CAPSULE [BIOGEN INC.]	15	Current NDC, Legacy NDC, 8 package rows	20241109_2d74414f-6b83-4ea2-9a95-3cecabbce774.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
Vumerity	DIROXIMEL FUMARATE	Biogen Inc.	2d74414f-6b83-4ea2-9a95-3cecabbce774	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211855 application number: NDA211855 ndc (product): 64406-020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K0N0Z40J3W	DIROXIMEL FUMARATE	1577222-14-0	DIROXIMEL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2261788	diroximel fumarate 231 MG Delayed Release Oral Capsule	PSN	2d74414f-6b83-4ea2-9a95-3cecabbce774	16
2261794	VUMERITY 231 MG Delayed Release Oral Capsule	PSN	2d74414f-6b83-4ea2-9a95-3cecabbce774	16
2261794	diroximel fumarate 231 MG Delayed Release Oral Capsule [Vumerity]	SBD	2d74414f-6b83-4ea2-9a95-3cecabbce774	16
2261788	diroximel fumarate 231 MG Delayed Release Oral Capsule	SCD	2d74414f-6b83-4ea2-9a95-3cecabbce774	16
2261794	Vumerity 231 MG Delayed Release Oral Capsule	SY	2d74414f-6b83-4ea2-9a95-3cecabbce774	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-020-01	64406002001	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-01) > 106 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29	0000-00-00	No	No	Current
64406-020-03	64406002003	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29	0000-00-00	No	No	Current
64406-020-05	64406002005	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-05) > 106 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29	0000-00-00	Yes	No	Current
64406-020-07	64406002007	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC	2022-09-01	0000-00-00	Yes	No	Current