Komzifti

Product NDC
84696-200
Requested package NDC
84696-200-90
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220305-001KOMZIFTIZIFTOMENIB200MGCAPSULE / ORALRLD, RS2025-11-13

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220305-001100772712036-03-16Drug substance, Drug product2025-12-10
N220305-001101740412036-03-16U-43502025-12-10
N220305-001101740412036-03-16U-43542025-12-10
N220305-001108698682037-01-26U-43522025-12-10
N220305-001108698682037-01-26U-43532025-12-10
N220305-001107812182037-03-15Drug substance, Drug product2025-12-10
N220305-001116738982037-03-15U-43502025-12-10
N220305-001116738982037-03-15U-43512025-12-10
N220305-001119446272038-09-06U-43472025-12-10
N220305-001119446272038-09-06U-43492025-12-10
N220305-001124101842044-07-16U-4347Drug substance, Drug product2025-12-10
N220305-001124101842044-07-16U-4348Drug substance, Drug product2025-12-10
N220305-001125213962044-07-16Drug product2026-01-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220305-001NCE2030-11-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-13c2088c7a36db…
2026-09-14 22:38:342026-08N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-1384e616aacf4f…
2026-08-18 06:07:402026-07N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220305-001KOMZIFTI200MGCAPSULE / ORALRLD, RS2025-11-13a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 77 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N220305-001100772712036-03-16Drug substance, Drug product2025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001101740412036-03-16U-43502025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001101740412036-03-16U-43542025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001108698682037-01-26U-43522025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001108698682037-01-26U-43532025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001107812182037-03-15Drug substance, Drug product2025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001116738982037-03-15U-43502025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001116738982037-03-15U-43512025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001119446272038-09-06U-43472025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001119446272038-09-06U-43492025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001124101842044-07-16U-4347Drug substance, Drug product2025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001124101842044-07-16U-4348Drug substance, Drug product2025-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N220305-001125213962044-07-16Drug product2026-01-21c2088c7a36db…
2026-09-14 22:38:342026-08N220305-001100772712036-03-16Drug substance, Drug product2025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001101740412036-03-16U-43502025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001101740412036-03-16U-43542025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001108698682037-01-26U-43522025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001108698682037-01-26U-43532025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001107812182037-03-15Drug substance, Drug product2025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001116738982037-03-15U-43502025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001116738982037-03-15U-43512025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001119446272038-09-06U-43472025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001119446272038-09-06U-43492025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001124101842044-07-16U-4347Drug substance, Drug product2025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001124101842044-07-16U-4348Drug substance, Drug product2025-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N220305-001125213962044-07-16Drug product2026-01-2184e616aacf4f…
2026-08-18 06:07:402026-07N220305-001100772712036-03-16Drug substance, Drug product2025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001101740412036-03-16U-43502025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001101740412036-03-16U-43542025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001108698682037-01-26U-43522025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001108698682037-01-26U-43532025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001107812182037-03-15Drug substance, Drug product2025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001116738982037-03-15U-43502025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001116738982037-03-15U-43512025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001119446272038-09-06U-43472025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001119446272038-09-06U-43492025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001124101842044-07-16U-4347Drug substance, Drug product2025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001124101842044-07-16U-4348Drug substance, Drug product2025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N220305-001125213962044-07-16Drug product2026-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220305-001100772712036-03-16Drug substance, Drug product2025-12-10011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N220305-001NCE2030-11-13c2088c7a36db…
2026-09-14 22:38:342026-08N220305-001NCE2030-11-1384e616aacf4f…
2026-08-18 06:07:402026-07N220305-001NCE2030-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220305-001NCE2030-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220305-001NCE2030-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220305-001NCE2030-11-13a50c72e98297…

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
IngredientStrength
ZIFTOMENIB200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4MOD1F4ENCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725990Internal RxNorm lookup
2725996Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b650f696-3391-4274-8b55-a5f5e9d04769Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84696-200-90Komzifti90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84696-200-90EA - Each84696-200cfe31590-eaae-4cd7-a44d-8a2d619f24d612026-01-08

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KomziftiZIFTOMENIBKura Oncology, Inc.b650f696-3391-4274-8b55-a5f5e9d047692025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220305
application number: NDA220305
ndc (package): 84696-200-90
ndc (product): 84696-200
ndc11 (package): 84696020090

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725996komzifti 200 MG Oral CapsulePSNb650f696-3391-4274-8b55-a5f5e9d047691
2725990ziftomenib 200 MG Oral CapsulePSNb650f696-3391-4274-8b55-a5f5e9d047691
2725996ziftomenib 200 MG Oral Capsule [Komzifti]SBDb650f696-3391-4274-8b55-a5f5e9d047691
2725990ziftomenib 200 MG Oral CapsuleSCDb650f696-3391-4274-8b55-a5f5e9d047691
2725996Komzifti 200 MG Oral CapsuleSYb650f696-3391-4274-8b55-a5f5e9d047691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84696-200-908469602009090 CAPSULE in 1 BOTTLE (84696-200-90) 90 capsule2025-11-13NoNoCurrent