Home NDC 72694-617 TIBSOVO
Product NDC 72694-617
11-digit product format 726940617
Labeler code 72694
Product ID 72694-617_190606ed-cb7f-411b-8548-cc2f98e57819
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ivosidenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Servier Pharmaceutical LLC
Application NDA211192
Marketing category NDA
Marketing start 2021-10-19
Substance IVOSIDENIB
Active strength 250 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Isocitrate Dehydrogenase 1 Inhibitor [EPC], Isocitrate Dehydrogenase 1 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211192-001 TIBSOVO IVOSIDENIB 250MG TABLET / ORAL RLD, RS 2018-07-20
Orange Book patents# Current patent rows page 1 of 1 · 31 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211192-001 10610125 2030-06-21 U-2784 2020-04-28 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3213 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3386 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2350 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2533 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2534 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3213 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3386 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3742 Drug substance, Drug product 2018-08-13 N211192-001 10449184 2035-03-13 Drug product 2019-11-12 N211192-001 10799490 2035-03-13 U-2981 Drug product 2020-11-06 N211192-001 10799490 2035-03-13 U-2982 Drug product 2020-11-06 N211192-001 10799490 2035-03-13 U-3384 Drug product 2020-11-06 N211192-001 9968595 2035-03-13 U-2351 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-2533 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-2534 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-3384 Drug product 2018-08-13 N211192-001 10653710 2036-10-18 U-3387 2022-06-23 N211192-001 10980788 2039-06-07 U-3112 2021-05-20 N211192-001 10980788 2039-06-07 U-3113 2021-05-20 N211192-001 10980788 2039-06-07 U-3214 2021-05-20 N211192-001 10980788 2039-06-07 U-3383 2021-05-20 N211192-001 10980788 2039-06-07 U-3743 2021-05-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 · 43 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 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,082 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 N211192-001 10610125 2030-06-21 U-2784 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3386 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3213 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2534 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2533 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2350 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3742 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3386 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3213 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10449184 2035-03-13 Drug product 2019-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-3384 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-2981 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-2982 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2534 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2533 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2351 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-3384 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10653710 2036-10-18 U-3387 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3214 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3743 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3383 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3112 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3113 2021-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-2784 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 247 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 TIBSOVO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVOSIDENIB 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q2PCN8MAM6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049878 Internal RxNorm lookup 2049884 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 72694-617-60 TIBSOVO 60 in 1 BOTTLE TABLET, FILM COATED 60 11 72694-617-60 TIBSOVO 1 in 1 CARTON TABLET, FILM COATED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72694-617 TIBSOVO (IVOSIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICAL LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240921_65d254c0-67ad-42c4-b972-ad463b755b2d.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 TIBSOVO IVOSIDENIB Servier Pharmaceutical LLC 65d254c0-67ad-42c4-b972-ad463b755b2d 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211192 application number: NDA211192 ndc (product): 72694-617
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 72694-617-60 72694061760 1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-10-19 0000-00-00 No No Current