FDA.reportPublic FDA data

Velsipity

Product NDC
63539-274
11-digit product format
635390274
Labeler code
63539
Product ID
63539-274_e566a7bd-2d3f-40f6-afc8-b2b24f563530
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etrasimod
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA216956
Marketing category
NDA
Marketing start
2023-11-09
Substance
ETRASIMOD ARGININE
Active strength
2 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63539-274DDiscontinued by firm2026-07-31
excluded packagepackage63539-27463539-274-28DDiscontinued by firm2026-07-31
excluded packagepackage63539-27463539-274-30DDiscontinued 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
N216956-001VELSIPITYETRASIMOD ARGININEEQ 2MG BASETABLET / ORALRLD, RS2023-10-12

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216956-00191269322029-07-22U-37322023-11-09
N216956-00185808412030-03-05Drug substance, Drug product2023-11-09
N216956-001110071752036-01-06U-37302023-11-09
N216956-001121568662036-01-06U-40472024-12-20
N216956-001123770712036-01-06U-42552025-09-03
N216956-001103012622036-06-21Drug substance, Drug product2023-11-09
N216956-001106764352036-06-21U-37312023-11-09
N216956-001110914352036-06-21Drug substance, Drug product2023-11-09
N216956-001118846262036-06-21U-37312024-02-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216956-001NCE2028-10-12

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 22:54:322026-06N216956-001VELSIPITYEQ 2MG BASETABLET / ORALRLD, RS2023-10-12a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N216956-00191269322029-07-22U-37322023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-00185808412030-03-05Drug substance, Drug product2023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-001110071752036-01-06U-37302023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-001121568662036-01-06U-40472024-12-20a50c72e98297…
2026-08-01 22:54:322026-06N216956-001123770712036-01-06U-42552025-09-03a50c72e98297…
2026-08-01 22:54:322026-06N216956-001103012622036-06-21Drug substance, Drug product2023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-001106764352036-06-21U-37312023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-001110914352036-06-21Drug substance, Drug product2023-11-09a50c72e98297…
2026-08-01 22:54:322026-06N216956-001118846262036-06-21U-37312024-02-28a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N216956-001NCE2028-10-12a50c72e98297…

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
VelsipityETRASIMODPfizer Laboratories Div Pfizer Inc65171e4a-d136-4abc-b08c-c40c1b486ff62025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 216956
application number: NDA216956

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46fbdc6c-ba2f-4b63-9daa-f943aa37b142Product name120250627
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-274-28Velsipity28 in 1 BLISTER PACKTABLET, FILM COATED284
63539-274-30Velsipity1 in 1 CARTONTABLET, FILM COATED14
63539-274-30Velsipity30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-274VELSIPITY (ETRASIMOD) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2Current NDC, 3 package rows20240927_d5b2a717-1b5c-4aed-a69c-64a0c4561c40.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63539-274-286353902742828 TABLET, FILM COATED in 1 BLISTER PACK (63539-274-28) 2023-11-09YesNoHistorical
63539-274-30635390274301 BOTTLE in 1 CARTON (63539-274-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-11-09YesNoHistorical