Home NDC 64842-0127-7 LYTGOBI
Product NDC 64842-0127
Requested package NDC 64842-0127-7
11-digit product format 648420127
Labeler code 64842
Product ID 64842-0127_87b2e0c4-3351-4a85-b721-19a0574daafa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FUTIBATINIB
Dosage form TABLET
Route ORAL
Labeler TAIHO PHARMACEUTICAL CO., LTD.
Application NDA214801
Marketing category NDA
Marketing start 2026-06-01
Substance FUTIBATINIB
Active strength 16 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein 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 N214801-001 LYTGOBI FUTIBATINIB 4MG TABLET / ORAL RLD, RS 2022-09-30 N214801-002 LYTGOBI FUTIBATINIB 16MG TABLET / ORAL RLD 2025-07-28
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 N214801-002 11833151 2039-11-05 Drug product 2025-09-11
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 2026-09-14 22:38:34 2026-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 88 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 N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-002 11833151 2039-11-05 Drug product 2025-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-002 11833151 2039-11-05 Drug product 2025-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-002 11833151 2039-11-05 Drug product 2025-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-002 11833151 2039-11-05 Drug product 2025-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 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 LYTGOBI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FUTIBATINIB 16 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B93MGE4AL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 14 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64842-0127-7 64842012707 1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACK 1 blister pack 2026-06-01 No No Current