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

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