Home NDC 71332-005 REZLIDHIA
Product NDC 71332-005
11-digit product format 713320005
Labeler code 71332
Product ID 71332-005_6df73356-e3c1-498d-af08-c34b5d257bdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olutasidenib
Dosage form CAPSULE
Route ORAL
Labeler Rigel Pharmaceuticals, Inc.
Application NDA215814
Marketing category NDA
Marketing start 2022-12-01
Substance OLUTASIDENIB
Active strength 150 mg/1
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 N215814-001 REZLIDHIA OLUTASIDENIB 150MG CAPSULE / ORAL RLD, RS 2022-12-01
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215814-001 10414752 2035-09-18 Drug product 2023-01-03 N215814-001 10550098 2035-09-18 Drug product 2023-01-03 N215814-001 11498913 2035-09-18 Drug product 2023-01-03 N215814-001 12275715 2035-09-18 U-3684 Drug substance, Drug product 2025-05-05 N215814-001 9834539 2035-09-18 U-3497 Drug substance, Drug product 2023-01-03 N215814-001 10532047 2039-05-16 Drug substance 2023-01-03 N215814-001 10959994 2039-05-16 Drug product 2023-01-03 N215814-001 11013733 2039-05-16 U-3496 2023-01-03 N215814-001 11013734 2039-05-16 U-3495 2023-01-03 N215814-001 11376246 2039-05-16 U-3495 2023-01-03 N215814-001 11497743 2039-05-16 U-3495 2023-01-03 N215814-001 12053463 2039-05-16 Drug substance, Drug product 2024-08-28 N215814-001 11738018 2039-07-17 U-3684 2023-09-14 N215814-001 11723905 2039-11-12 Drug product 2023-09-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215814-001 NCE 2027-12-01 N215814-001 ODE-413 2029-12-01
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 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215814-001 REZLIDHIA 150MG CAPSULE / ORAL RLD, RS 2022-12-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 323 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 N215814-001 10414752 2035-09-18 Drug product 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 10550098 2035-09-18 Drug product 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11498913 2035-09-18 Drug product 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 12275715 2035-09-18 U-3684 Drug substance, Drug product 2025-05-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 9834539 2035-09-18 U-3497 Drug substance, Drug product 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 10532047 2039-05-16 Drug substance 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 10959994 2039-05-16 Drug product 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11013733 2039-05-16 U-3496 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11013734 2039-05-16 U-3495 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11376246 2039-05-16 U-3495 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11497743 2039-05-16 U-3495 2023-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 12053463 2039-05-16 Drug substance, Drug product 2024-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11738018 2039-07-17 U-3684 2023-09-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215814-001 11723905 2039-11-12 Drug product 2023-09-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215814-001 10414752 2035-09-18 Drug product 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 10550098 2035-09-18 Drug product 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11498913 2035-09-18 Drug product 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 12275715 2035-09-18 U-3684 Drug substance, Drug product 2025-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 9834539 2035-09-18 U-3497 Drug substance, Drug product 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 10532047 2039-05-16 Drug substance 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 10959994 2039-05-16 Drug product 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11013733 2039-05-16 U-3496 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11013734 2039-05-16 U-3495 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11376246 2039-05-16 U-3495 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11497743 2039-05-16 U-3495 2023-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 12053463 2039-05-16 Drug substance, Drug product 2024-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11738018 2039-07-17 U-3684 2023-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215814-001 11723905 2039-11-12 Drug product 2023-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215814-001 10414752 2035-09-18 Drug product 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 10550098 2035-09-18 Drug product 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 11498913 2035-09-18 Drug product 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 12275715 2035-09-18 U-3684 Drug substance, Drug product 2025-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 9834539 2035-09-18 U-3497 Drug substance, Drug product 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 10532047 2039-05-16 Drug substance 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 10959994 2039-05-16 Drug product 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 11013733 2039-05-16 U-3496 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 11013734 2039-05-16 U-3495 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 11376246 2039-05-16 U-3495 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 11497743 2039-05-16 U-3495 2023-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215814-001 12053463 2039-05-16 Drug substance, Drug product 2024-08-28 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
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 REZLIDHIA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLUTASIDENIB 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0T4IMT8S5Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2623648 Internal RxNorm lookup 2623654 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 71332-005-01 REZLIDHIA 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71332-005 REZLIDHIA (OLUTASIDENIB) CAPSULE [RIGEL PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250516_4a0c7c8b-b95f-455d-9600-b7351e4397fe.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join REZLIDHIA OLUTASIDENIB Rigel Pharmaceuticals, Inc. 4a0c7c8b-b95f-455d-9600-b7351e4397fe 2025-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215814 application number: NDA215814 ndc (product): 71332-005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71332-005-01 71332000501 30 CAPSULE in 1 BOTTLE (71332-005-01) 30 capsule 2022-12-01 0000-00-00 No No Current