Home NDC 63539-274-30 Velsipity
Product NDC 63539-274
Requested package NDC 63539-274-30
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216956-001 VELSIPITY ETRASIMOD ARGININE EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216956-001 9126932 2029-07-22 U-3732 2023-11-09 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 N216956-001 12377071 2036-01-06 U-4255 2025-09-03 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 N216956-001 11884626 2036-06-21 U-3731 2024-02-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216956-001 NCE 2028-10-12
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 134 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 12377071 2036-01-06 U-4255 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 12377071 2036-01-06 U-4255 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 b8a1b40f171c…
Observed Orange Book exclusivity history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Velsipity ETRASIMOD Pfizer Laboratories Div Pfizer Inc 65171e4a-d136-4abc-b08c-c40c1b486ff6 2025-08-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 216956 application number: NDA216956
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-274-28 Velsipity 28 in 1 BLISTER PACK TABLET, FILM COATED 28 4 63539-274-30 Velsipity 1 in 1 CARTON TABLET, FILM COATED 1 4 63539-274-30 Velsipity 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-274 VELSIPITY (ETRASIMOD) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 Current NDC, 3 package rows 20240927_d5b2a717-1b5c-4aed-a69c-64a0c4561c40.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63539-274-30 63539027430 1 BOTTLE in 1 CARTON (63539-274-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-11-09 Yes No Historical