Home NDC 64842-1025 LONSURF
Product NDC 64842-1025
11-digit product format 648421025
Labeler code 64842
Product ID 64842-1025_15b86e86-8940-44e3-921c-2e0b97180ea1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trifluridine and tipiracil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Taiho Pharmaceutical Co., Ltd.
Application NDA207981
Marketing category NDA
Marketing start 2015-09-22
Substance TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE
Active strength 15; 6.14 mg/1; mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase 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 N207981-001 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 N207981-002 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N207981-001 ODE-229 2026-02-22 N207981-002 ODE-229 2026-02-22
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 3 · 86 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 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Observed Orange Book patent history# Patent history page 1 of 17 · 680 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 N207981-001 RE46284 2029-09-22 U-2503 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 RE46284 2029-09-22 U-1751 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 RE46284 2029-09-22 U-3656 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 9943537 2034-09-05 U-3659 2023-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10456399 2037-02-03 U-3657 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10456399 2037-02-03 U-3658 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10960004 2037-02-03 U-3657 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10960004 2037-02-03 U-3658 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-1751 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-2503 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-3656 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 9943537 2034-09-05 U-3659 2023-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10456399 2037-02-03 U-3658 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10456399 2037-02-03 U-3657 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10960004 2037-02-03 U-3657 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10960004 2037-02-03 U-3658 2021-04-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-2503 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-1751 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-3656 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 9943537 2034-09-05 U-3659 2023-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10456399 2037-02-03 U-3657 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10456399 2037-02-03 U-3658 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10960004 2037-02-03 U-3657 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10960004 2037-02-03 U-3658 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-1751 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-2503 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-3656 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 9943537 2034-09-05 U-3659 2023-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10456399 2037-02-03 U-3658 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10456399 2037-02-03 U-3657 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10960004 2037-02-03 U-3657 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10960004 2037-02-03 U-3658 2021-04-09 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 134 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 LONSURF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIFLURIDINE 15 mg/1 TIPIRACIL HYDROCHLORIDE 6.14 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4H59KLQ0A4 Internal UNII lookup RMW9V5RW38 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1670311 Internal RxNorm lookup 1670316 Internal RxNorm lookup 1670322 Internal RxNorm lookup 1670324 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 64842-1025-1 LONSURF 20 in 1 BOTTLE TABLET, FILM COATED 20 15 64842-1025-2 LONSURF 40 in 1 BOTTLE TABLET, FILM COATED 40 15 64842-1025-3 LONSURF 60 in 1 BOTTLE TABLET, FILM COATED 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIPIRACIL HYDROCHLORIDE ACTIVE INGREDIENT 4H59KLQ0A4 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 TRIFLURIDINE ACTIVE INGREDIENT RMW9V5RW38 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 TIPIRACIL ACTIVE MOIETY NGO10K751P LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 TRIFLURIDINE ACTIVE MOIETY RMW9V5RW38 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64842-1025 LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 14 Current NDC, Legacy NDC, 3 package rows 20241213_f5beed22-d71d-4c0d-8dca-2c7317d65d85.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 LONSURF TRIFLURIDINE AND TIPIRACIL Taiho Pharmaceutical Co., Ltd. f5beed22-d71d-4c0d-8dca-2c7317d65d85 2025-11-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 207981 application number: NDA207981 ndc (product): 64842-1025
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64842-1025-1 64842102501 20 TABLET, FILM COATED in 1 BOTTLE (64842-1025-1) 2015-10-07 0000-00-00 No No Current 64842-1025-2 64842102502 40 TABLET, FILM COATED in 1 BOTTLE (64842-1025-2) 2015-11-11 0000-00-00 No No Current 64842-1025-3 64842102503 60 TABLET, FILM COATED in 1 BOTTLE (64842-1025-3) 2015-10-21 0000-00-00 No No Current