Home NDC 87211-030 LISRAYA
Product NDC 87211-030
11-digit product format 872110030
Labeler code 87211
Product ID 87211-030_4ea28f02-7a6c-4e71-86ba-8c516f6d9323
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brepocitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Priovant Therapeutics, Inc.
Application NDA220106
Marketing category NDA
Marketing start 2026-08-27
Substance BREPOCITINIB TOSYLATE
Active strength 30 mg/1
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 44 .
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 N220106-001 LISRAYA BREPOCITINIB TOSYLATE EQ 30MG BASE TABLET / ORAL RLD, RS 2026-08-27
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220106-001 11197867 2035-08-19 Drug substance, Drug product 2026-09-22 N220106-001 9663526 2035-08-19 Drug substance, Drug product 2026-09-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220106-001 NCE 2031-08-27
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 2026-10-15 13:18:30 2026-09 N220106-001 LISRAYA EQ 30MG BASE TABLET / ORAL RLD, RS 2026-08-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220106-001 LISRAYA EQ 30MG BASE TABLET / ORAL RLD, RS 2026-08-27 84e616aacf4f…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N220106-001 11197867 2035-08-19 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220106-001 9663526 2035-08-19 Drug substance, Drug product 2026-09-22 c2088c7a36db…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N220106-001 NCE 2031-08-27 c2088c7a36db…
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 LISRAYA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BREPOCITINIB TOSYLATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C960DPP15O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2751541 Internal RxNorm lookup 2751547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LISRAYA BREPOCITINIB Priovant Therapeutics, Inc. 5023a17b-e96a-67d4-e063-6394a90a14a7 2026-08-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 220106 application number: NDA220106 ndc (product): 87211-030
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87211-030-30 87211003030 1 BOTTLE in 1 CARTON (87211-030-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-08-27 No No Current