FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii4MOD1F4ENC
Rxcui2725990, 2725996

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

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