Home NDC 84696-200 Komzifti
Product NDC 84696-200
11-digit product format 846960200
Labeler code 84696
Product ID 84696-200_3213879b-dd88-413b-9910-8fd422c99805
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ziftomenib
Dosage form CAPSULE
Route ORAL
Labeler Kura Oncology, Inc.
Application NDA220305
Marketing category NDA
Marketing start 2025-11-13
Substance ZIFTOMENIB
Active strength 200 mg/1
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 44 .
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 N220305-001 KOMZIFTI ZIFTOMENIB 200MG CAPSULE / ORAL RLD, RS 2025-11-13
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220305-001 10077271 2036-03-16 Drug substance, Drug product 2025-12-10 N220305-001 10174041 2036-03-16 U-4350 2025-12-10 N220305-001 10174041 2036-03-16 U-4354 2025-12-10 N220305-001 10869868 2037-01-26 U-4352 2025-12-10 N220305-001 10869868 2037-01-26 U-4353 2025-12-10 N220305-001 10781218 2037-03-15 Drug substance, Drug product 2025-12-10 N220305-001 11673898 2037-03-15 U-4350 2025-12-10 N220305-001 11673898 2037-03-15 U-4351 2025-12-10 N220305-001 11944627 2038-09-06 U-4347 2025-12-10 N220305-001 11944627 2038-09-06 U-4349 2025-12-10 N220305-001 12410184 2044-07-16 U-4347 Drug substance, Drug product 2025-12-10 N220305-001 12410184 2044-07-16 U-4348 Drug substance, Drug product 2025-12-10 N220305-001 12521396 2044-07-16 Drug product 2026-01-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220305-001 NCE 2030-11-13
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 2026-10-15 13:18:30 2026-09 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220305-001 KOMZIFTI 200MG CAPSULE / ORAL RLD, RS 2025-11-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 77 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N220305-001 10077271 2036-03-16 Drug substance, Drug product 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 10174041 2036-03-16 U-4350 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 10174041 2036-03-16 U-4354 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 10869868 2037-01-26 U-4352 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 10869868 2037-01-26 U-4353 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 10781218 2037-03-15 Drug substance, Drug product 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 11673898 2037-03-15 U-4350 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 11673898 2037-03-15 U-4351 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 11944627 2038-09-06 U-4347 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 11944627 2038-09-06 U-4349 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 12410184 2044-07-16 U-4347 Drug substance, Drug product 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 12410184 2044-07-16 U-4348 Drug substance, Drug product 2025-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220305-001 12521396 2044-07-16 Drug product 2026-01-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220305-001 10077271 2036-03-16 Drug substance, Drug product 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 10174041 2036-03-16 U-4350 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 10174041 2036-03-16 U-4354 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 10869868 2037-01-26 U-4352 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 10869868 2037-01-26 U-4353 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 10781218 2037-03-15 Drug substance, Drug product 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 11673898 2037-03-15 U-4350 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 11673898 2037-03-15 U-4351 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 11944627 2038-09-06 U-4347 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 11944627 2038-09-06 U-4349 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 12410184 2044-07-16 U-4347 Drug substance, Drug product 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 12410184 2044-07-16 U-4348 Drug substance, Drug product 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220305-001 12521396 2044-07-16 Drug product 2026-01-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220305-001 10077271 2036-03-16 Drug substance, Drug product 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 10174041 2036-03-16 U-4350 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 10174041 2036-03-16 U-4354 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 10869868 2037-01-26 U-4352 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 10869868 2037-01-26 U-4353 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 10781218 2037-03-15 Drug substance, Drug product 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 11673898 2037-03-15 U-4350 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 11673898 2037-03-15 U-4351 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 11944627 2038-09-06 U-4347 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 11944627 2038-09-06 U-4349 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 12410184 2044-07-16 U-4347 Drug substance, Drug product 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 12410184 2044-07-16 U-4348 Drug substance, Drug product 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220305-001 12521396 2044-07-16 Drug product 2026-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N220305-001 10077271 2036-03-16 Drug substance, Drug product 2025-12-10 011fe1cb6892…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N220305-001 NCE 2030-11-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220305-001 NCE 2030-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220305-001 NCE 2030-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N220305-001 NCE 2030-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N220305-001 NCE 2030-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220305-001 NCE 2030-11-13 a50c72e98297…
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 Komzifti
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIFTOMENIB 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4MOD1F4ENC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725990 Internal RxNorm lookup 2725996 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84696-200-90 Komzifti 90 in 1 BOTTLE CAPSULE 90 1
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 84696-200-90 84696020090 90 CAPSULE in 1 BOTTLE (84696-200-90) 90 capsule 2025-11-13 No No Current