FDA.reportPublic FDA data

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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64406-02064406-020-01DDiscontinued by firm2026-07-31
excluded packagepackage64406-02064406-020-05DDiscontinued by firm2026-07-31

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211855-001VUMERITYDIROXIMEL FUMARATE231MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2019-10-29

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211855-001100807332033-09-20U-1384Drug substance, Drug product2019-11-22
N211855-00190905582033-09-20U-13842019-11-22
N211855-00186692812033-10-29Drug substance, Drug product2019-11-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N211855-001VUMERITY231MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2019-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N211855-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N211855-001100807332033-09-20U-1384Drug substance, Drug product2019-11-22a50c72e98297…
2026-08-01 22:54:322026-06N211855-00190905582033-09-20U-13842019-11-22a50c72e98297…
2026-08-01 22:54:322026-06N211855-00186692812033-10-29Drug substance, Drug product2019-11-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VumerityDIROXIMEL FUMARATEBiogen Inc.2d74414f-6b83-4ea2-9a95-3cecabbce7742025-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 211855
application number: NDA211855
ndc (product): 64406-020

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIROXIMEL FUMARATE231 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K0N0Z40J3WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2261788Internal RxNorm lookup
2261794Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d74414f-6b83-4ea2-9a95-3cecabbce774Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64406-020-012024-08-07C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-032024-08-07C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-052024-08-07C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-072024-08-07C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-012024-07-30C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-032024-07-30C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-052024-07-30C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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
64406-020-072024-07-30C16284748780-11e7a6dab-175b-a2ce-e063-dadaa90aadf7These 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 NDCProductDescriptionFormQuantityStrengthSPL version
64406-020-01Vumerity1 in 1 CARTONCAPSULE116
64406-020-01Vumerity106 in 1 BOTTLE, PLASTICCAPSULE10616
64406-020-03Vumerity120 in 1 BOTTLE, PLASTICCAPSULE12016
64406-020-03Vumerity1 in 1 CARTONCAPSULE116
64406-020-05Vumerity1 in 1 CARTONCAPSULE116
64406-020-05Vumerity106 in 1 BOTTLE, PLASTICCAPSULE10616
64406-020-07Vumerity14 in 1 BOTTLE, PLASTICCAPSULE1416
64406-020-07Vumerity1 in 1 CARTONCAPSULE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-020-01EA - Each64406-020f9e25515-bd78-4ae5-af07-9d98a07ffc5712019-12-10
64406-020-03EA - Each64406-020584752e0-9497-404b-b4e8-458af39719c612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-020VUMERITY (DIROXIMEL FUMARATE) CAPSULE [BIOGEN INC.]15Current NDC, Legacy NDC, 8 package rows20241109_2d74414f-6b83-4ea2-9a95-3cecabbce774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2261788diroximel fumarate 231 MG Delayed Release Oral CapsulePSN2d74414f-6b83-4ea2-9a95-3cecabbce77416
2261794VUMERITY 231 MG Delayed Release Oral CapsulePSN2d74414f-6b83-4ea2-9a95-3cecabbce77416
2261794diroximel fumarate 231 MG Delayed Release Oral Capsule [Vumerity]SBD2d74414f-6b83-4ea2-9a95-3cecabbce77416
2261788diroximel fumarate 231 MG Delayed Release Oral CapsuleSCD2d74414f-6b83-4ea2-9a95-3cecabbce77416
2261794Vumerity 231 MG Delayed Release Oral CapsuleSY2d74414f-6b83-4ea2-9a95-3cecabbce77416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64406-020-01644060020011 BOTTLE, PLASTIC in 1 CARTON (64406-020-01) > 106 CAPSULE in 1 BOTTLE, PLASTIC2019-10-290000-00-00NoNoCurrent
64406-020-03644060020031 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC2019-10-290000-00-00NoNoCurrent
64406-020-05644060020051 BOTTLE, PLASTIC in 1 CARTON (64406-020-05) > 106 CAPSULE in 1 BOTTLE, PLASTIC2019-10-290000-00-00YesNoCurrent
64406-020-07644060020071 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC2022-09-010000-00-00YesNoCurrent