Home NDC 71334-100-01 Tibsovo
Product NDC 71334-100
Requested package NDC 71334-100-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 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 2026-08-01 22:54:32 2026-06 N211192-001 10610125 2030-06-21 U-2784 2020-04-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-3386 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9850277 2033-01-18 U-3213 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-2534 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-2533 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-2350 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-3742 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-3386 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9474779 2033-08-19 U-3213 Drug substance, Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10449184 2035-03-13 Drug product 2019-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10799490 2035-03-13 U-3384 Drug product 2020-11-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10799490 2035-03-13 U-2981 Drug product 2020-11-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10799490 2035-03-13 U-2982 Drug product 2020-11-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9968595 2035-03-13 U-2534 Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9968595 2035-03-13 U-2533 Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9968595 2035-03-13 U-2351 Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 9968595 2035-03-13 U-3384 Drug product 2018-08-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10653710 2036-10-18 U-3387 2022-06-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10980788 2039-06-07 U-3214 2021-05-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10980788 2039-06-07 U-3743 2021-05-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10980788 2039-06-07 U-3383 2021-05-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10980788 2039-06-07 U-3112 2021-05-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 10980788 2039-06-07 U-3113 2021-05-20 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N211192-001 ODE-242 2026-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 I-924 2026-10-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 ODE-368 2028-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N211192-001 ODE-447 2030-10-24 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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