Home NDC 65597-407 Turalio
Product NDC 65597-407
11-digit product format 655970407
Labeler code 65597
Product ID 65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pexidartinib hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Daiichi Sankyo Inc.
Application NDA211810
Marketing category NDA
Marketing start 2023-02-01
Substance PEXIDARTINIB HYDROCHLORIDE
Active strength 125 mg/1
Pharmacologic classes Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211810-001 TURALIO PEXIDARTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 N211810-002 TURALIO PEXIDARTINIB HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211810-001 ODE-250 2026-08-02 N211810-002 ODE* 2026-08-02
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.
Product history page 1 of 2 · 69 observed 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 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5aa47cf7b7d7…
Observed Orange Book patent history# Patent history page 1 of 20 · 799 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 N211810-001 8404700 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 8722702 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9169250 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 8461169 2028-04-19 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 7893075 2033-05-04 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9358235 2033-06-08 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10189833 2036-05-05 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10730876 2036-05-05 Drug substance 2020-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9802932 2036-05-05 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10435404 2038-07-24 Drug product 2019-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10941142 2038-07-24 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10961240 2038-07-24 U-2606 2021-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8404700 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8722702 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9169250 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8461169 2028-04-19 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 7893075 2033-05-04 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9358235 2033-06-08 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10189833 2036-05-05 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10730876 2036-05-05 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9802932 2036-05-05 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10435404 2038-07-24 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10941142 2038-07-24 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10961240 2038-07-24 U-2606 2022-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211810-001 8404700 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 8722702 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9169250 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 8461169 2028-04-19 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 7893075 2033-05-04 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9358235 2033-06-08 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10189833 2036-05-05 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10730876 2036-05-05 Drug substance 2020-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9802932 2036-05-05 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10435404 2038-07-24 Drug product 2019-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10941142 2038-07-24 Drug product 2021-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10961240 2038-07-24 U-2606 2021-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8404700 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8722702 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 9169250 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8461169 2028-04-19 U-2606 2022-11-14 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 119 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 Turalio
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEXIDARTINIB HYDROCHLORIDE 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YS6WAI3XN7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2626397 Internal RxNorm lookup 2626399 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 65597-407-20 Turalio 120 in 1 BOTTLE CAPSULE 120 8 65597-407-20 Turalio 1 in 1 CARTON CAPSULE 1 8 65597-407-28 Turalio 1 in 1 CARTON CAPSULE 1 8 65597-407-28 Turalio 28 in 1 BOTTLE CAPSULE 28 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65597-407 TURALIO (PEXIDARTINIB HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO INC.] 8 Current NDC, 4 package rows 20250119_7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16.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 Turalio PEXIDARTINIB HYDROCHLORIDE Daiichi Sankyo Inc. 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16 2025-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211810 application number: NDA211810 ndc (product): 65597-407
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65597-407-20 65597040720 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE 1 bottle 2023-02-01 No No Current 65597-407-28 65597040728 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE 1 bottle 2023-02-01 No No Current