Home NDC 71334-100 Tibsovo
Product NDC 71334-100
11-digit product format 713340100
Labeler code 71334
Product ID 71334-100_7618e704-4d61-4af1-8a05-1f521db4f309
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ivosidenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Agios Pharmaceuticals, Inc.
Application NDA211192
Marketing category NDA
Marketing start 2018-07-20
Marketing end 2024-11-30
Substance IVOSIDENIB
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71334-100-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71334-100-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71334-100-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71334-100-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71334-100-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71334-100-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71334-100-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71334-100-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71334-100-01 0efc9e666f02…f202fb6c5f17…
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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71334-100-01 71334010001 60 TABLET, FILM COATED in 1 BOTTLE (71334-100-01) 2018-07-20 2024-11-30 No No Current