Home NDC 84651-200 IBTROZI
Product NDC 84651-200
11-digit product format 846510200
Labeler code 84651
Product ID 84651-200_12274fa4-44f0-4e87-9683-67b1515ea180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name taletrectinib
Dosage form CAPSULE
Route ORAL
Labeler Nuvation Bio Inc.
Application NDA219713
Marketing category NDA
Marketing start 2025-06-11
Substance TALETRECTINIB ADIPATE
Active strength 272 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]
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 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 N219713-001 IBTROZI TALETRECTINIB ADIPATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11
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 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219713-001 NCE 2030-06-11 N219713-001 ODE-544 2032-06-11
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 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219713-001 IBTROZI EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-06-11 a50c72e98297…
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 2026-09-14 22:38:34 2026-08 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219713-001 9187489 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219713-001 9751887 2033-06-03 U-4207 Drug substance, Drug product 2025-06-27 a50c72e98297…
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 IBTROZI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TALETRECTINIB ADIPATE 272 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84651-200-30 IBTROZI 30 in 1 BOTTLE CAPSULE 30 4 84651-200-90 IBTROZI 90 in 1 BOTTLE CAPSULE 90 4 84651-200-90 IBTROZI 1 in 1 CARTON CAPSULE 1 4 84651-200-93 IBTROZI 3 in 1 CARTON CAPSULE 3 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84651-200-30 84651020030 30 in 1 BOTTLE Historical 84651-200-90 84651020090 1 BOTTLE in 1 CARTON (84651-200-90) / 90 CAPSULE in 1 BOTTLE 1 bottle 2026-09-01 No No Current 84651-200-93 84651020093 3 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30) 3 bottle 2025-06-13 No No Current