Home NDC 0069-0274 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 43 .
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 2026-09-14 22:38:34 2026-08 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216956-001 VELSIPITY EQ 2MG BASE TABLET / ORAL RLD, RS 2023-10-12 caaa826d4ba7…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 · 152 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 12377071 2036-01-06 U-4255 2025-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216956-001 9126932 2029-07-22 U-3732 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 8580841 2030-03-05 Drug substance, Drug product 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 11007175 2036-01-06 U-3730 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 12156866 2036-01-06 U-4047 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 12377071 2036-01-06 U-4255 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 10301262 2036-06-21 Drug substance, Drug product 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 10676435 2036-06-21 U-3731 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 11091435 2036-06-21 Drug substance, Drug product 2023-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216956-001 11884626 2036-06-21 U-3731 2024-02-28 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Velsipity
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETRASIMOD ARGININE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MXE5EMA09L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2668051 Internal RxNorm lookup 2668057 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0274-30 Velsipity 30 in 1 BOTTLE TABLET, FILM COATED 30 4 0069-0274-30 Velsipity 1 in 1 CARTON TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0274 VELSIPITY (ETRASIMOD) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 3 Current NDC, 2 package rows 20240622_65171e4a-d136-4abc-b08c-c40c1b486ff6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-0274-30 00069027430 1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-10-19 No No Current