FDA.reportPublic FDA data

Velsipity

Product NDC
0069-0274
11-digit product format
000690274
Labeler code
0069
Product ID
0069-0274_c2b3ca10-be3d-4c1c-b210-9ebefc065826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etrasimod
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA216956
Marketing category
NDA
Marketing start
2023-10-19
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
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 · 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
ndc (product): 0069-0274

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETRASIMOD ARGININE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MXE5EMA09LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2668051Internal RxNorm lookup
2668057Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65171e4a-d136-4abc-b08c-c40c1b486ff6Available on FDA.report

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
0069-0274-30Velsipity30 in 1 BOTTLETABLET, FILM COATED304
0069-0274-30Velsipity1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0274VELSIPITY (ETRASIMOD) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]3Current NDC, 2 package rows20240622_65171e4a-d136-4abc-b08c-c40c1b486ff6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668051etrasimod 2 MG Oral TabletPSN65171e4a-d136-4abc-b08c-c40c1b486ff64
2668057Velsipity 2 MG Oral TabletPSN65171e4a-d136-4abc-b08c-c40c1b486ff64
2668057etrasimod 2 MG Oral Tablet [Velsipity]SBD65171e4a-d136-4abc-b08c-c40c1b486ff64
2668051etrasimod 2 MG Oral TabletSCD65171e4a-d136-4abc-b08c-c40c1b486ff64
2668051etrasimod 2 MG (as etrasimod arginine 2.76 MG) Oral TabletSY65171e4a-d136-4abc-b08c-c40c1b486ff64
2668057Velsipity 2 MG Oral TabletSY65171e4a-d136-4abc-b08c-c40c1b486ff64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-0274-30000690274301 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-10-19NoNoCurrent