Home NDC 65597-504 VANFLYTA
Product NDC 65597-504
11-digit product format 655970504
Labeler code 65597
Product ID 65597-504_ee05ebbe-cace-4b2f-bb89-c26687c1eeaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name QUIZARTINIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Daiichi Sankyo Inc.
Application NDA216993
Marketing category NDA
Marketing start 2023-07-20
Substance QUIZARTINIB DIHYDROCHLORIDE
Active strength 17.7 mg/1
Pharmacologic classes FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N216993-001 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 N216993-002 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
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 · 44 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 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 a72a2bbeb626…
Observed Orange Book patent history# Patent history page 1 of 13 · 484 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 N216993-001 8129374 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8557810 2027-03-16 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8883783 2027-03-16 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9585892 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 7820657 2028-09-26 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 7968543 2029-08-15 U-3661 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8865710 2029-08-15 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8836218 2030-03-23 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9555040 2030-05-14 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8357690 2031-02-26 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9675549 2033-09-30 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8129374 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8557810 2027-03-16 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8883783 2027-03-16 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9585892 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 7820657 2028-09-26 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 7968543 2029-08-15 U-3661 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8865710 2029-08-15 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8836218 2030-03-23 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9555040 2030-05-14 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8357690 2031-02-26 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9675549 2033-09-30 Drug product 2023-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216993-001 8129374 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8557810 2027-03-16 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8883783 2027-03-16 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9585892 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 7820657 2028-09-26 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 7968543 2029-08-15 U-3661 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8865710 2029-08-15 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8836218 2030-03-23 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9555040 2030-05-14 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8357690 2031-02-26 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9675549 2033-09-30 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8129374 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8557810 2027-03-16 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8883783 2027-03-16 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 9585892 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 7820657 2028-09-26 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 7968543 2029-08-15 U-3661 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8865710 2029-08-15 Drug product 2023-08-11 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 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 VANFLYTA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK7Q6ZIZ10 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2643054 Internal RxNorm lookup 2643060 Internal RxNorm lookup 2643062 Internal RxNorm lookup 2643064 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 65597-504-04 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-04 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-04 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-02-05 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-04 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-04 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-04 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023 65597-504-28 2024-01-30 These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65597-504-04 VANFLYTA 14 in 1 BOTTLE TABLET, FILM COATED 14 11 65597-504-04 VANFLYTA 1 in 1 CARTON TABLET, FILM COATED 1 11 65597-504-28 VANFLYTA 1 in 1 CARTON TABLET, FILM COATED 1 11 65597-504-28 VANFLYTA 28 in 1 BOTTLE TABLET, FILM COATED 28 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65597-504 VANFLYTA (QUIZARTINIB) TABLET, FILM COATED [DAIICHI SANKYO INC.] 8 Current NDC, 4 package rows 20240709_29cdbcfe-497d-4e78-bb7b-2d4acafe8e86.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65597-504-04 65597050404 1 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-07-20 No No Current 65597-504-28 65597050428 1 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-07-20 No No Current