FDA.reportPublic FDA data

FOTIVDA

Product NDC
45629-089
11-digit product format
456290089
Labeler code
45629
Product ID
45629-089_40222ff4-0ffc-318f-e063-6294a90aadc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tivozanib
Dosage form
CAPSULE
Route
ORAL
Labeler
AVEO Pharmaceuticals, Inc.
Application
NDA212904
Marketing category
NDA
Marketing start
2021-03-10
Substance
TIVOZANIB HYDROCHLORIDE
Active strength
.89 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FOTIVDA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIVOZANIB HYDROCHLORIDE.89 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8A9H4VK35Z
Rxcui2534238, 2534244, 2534247, 2534249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9c90f50f-ee2c-4dd2-9565-428b003bafedProduct name120210903

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45629-089-012025-08-14C16284748780-1e4f33bdf-b153-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FOTIVDA safely and effectively. See full prescribing information for FOTIVDA. FOTIVDA ® (tivozanib) capsules, for oral use Initial U.S. Approval: 2021
45629-089-012025-07-29C16284748780-1e4f33bdf-b153-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FOTIVDA safely and effectively. See full prescribing information for FOTIVDA. FOTIVDA ® (tivozanib) capsules, for oral use Initial U.S. Approval: 2021
45629-089-012022-08-25C16284748780-1e4f33bdf-b153-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FOTIVDA safely and effectively. See full prescribing information for FOTIVDA. FOTIVDA ® (tivozanib) capsules, for oral use Initial U.S. Approval: 2021
45629-089-012022-07-29C16284748780-1e4f33bdf-b153-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FOTIVDA safely and effectively. See full prescribing information for FOTIVDA. FOTIVDA ® (tivozanib) capsules, for oral use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45629-089-01FOTIVDA21 in 1 BOTTLE, PLASTICCAPSULE2113
45629-089-01FOTIVDA1 in 1 BAGCAPSULE113
45629-089-02FOTIVDA21 in 1 BOTTLE, PLASTICCAPSULE2113
45629-089-02FOTIVDA1 in 1 CARTONCAPSULE113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45629-089-01EA - Each45629-089acf24915-29fa-4967-b7df-790ca8ebabcb12021-04-08
45629-089-02EA - Each45629-089a68d41fc-e4f9-40b3-8277-a87d59e906fe12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45629-089FOTIVDA (TIVOZANIB) CAPSULE [AVEO PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20250524_de77155c-ecf2-4f15-9758-21d271449d83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2534244FOTIVDA 0.89 MG Oral CapsulePSNde77155c-ecf2-4f15-9758-21d271449d8313
2534249FOTIVDA 1.34 MG Oral CapsulePSNde77155c-ecf2-4f15-9758-21d271449d8313
2534238tivozanib 0.89 MG Oral CapsulePSNde77155c-ecf2-4f15-9758-21d271449d8313
2534247tivozanib 1.34 MG Oral CapsulePSNde77155c-ecf2-4f15-9758-21d271449d8313
2534244tivozanib 0.89 MG Oral Capsule [Fotivda]SBDde77155c-ecf2-4f15-9758-21d271449d8313
2534249tivozanib 1.34 MG Oral Capsule [Fotivda]SBDde77155c-ecf2-4f15-9758-21d271449d8313
2534238tivozanib 0.89 MG Oral CapsuleSCDde77155c-ecf2-4f15-9758-21d271449d8313
2534247tivozanib 1.34 MG Oral CapsuleSCDde77155c-ecf2-4f15-9758-21d271449d8313
2534244Fotivda (as tivozanib hydrochloride 1 MG) 0.89 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313
2534249Fotivda (as tivozanib hydrochloride 1.5 MG) 1.34 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313
2534244Fotivda 0.89 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313
2534249Fotivda 1.34 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313
2534238tivozanib (as tivozanib hydrochloride 1 MG) 0.89 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313
2534247tivozanib (as tivozanib hydrochloride 1.5 MG) 1.34 MG Oral CapsuleSYde77155c-ecf2-4f15-9758-21d271449d8313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45629-089-01456290089011 BOTTLE, PLASTIC in 1 BAG (45629-089-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC2021-03-100000-00-00NoNoCurrent
45629-089-02456290089021 BOTTLE, PLASTIC in 1 CARTON (45629-089-02) / 21 CAPSULE in 1 BOTTLE, PLASTIC2025-01-30NoNoHistorical