Jevtana

Product NDC
0024-5824
11-digit product format
000245824
Labeler code
0024
Product ID
0024-5824_66314b60-5135-400e-933a-d4974397fdaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cabazitaxel
Dosage form
KIT
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA201023
Marketing category
NDA
Marketing start
2010-06-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1001433, 1376084

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
693bce7d-1304-46b2-b354-48391f4bc5afProduct name120240103
87c8b5ae-ec58-4574-92b9-77376c45dd7dProduct name120230921
0b924aa0-964b-4c17-a3a3-7ba55d6fd148Product name120220921

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5823-15Jevtana5.7 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE5.7 mL60 mg in 1.5mL27
0024-5824-11Jevtana1 in 1 CARTONKIT127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5824-11ML - Milliliter0024-5824a2653cce-5d51-4555-900e-4bfebdcc59f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cabazitaxelACTIVE INGREDIENT51F690397JJEVTANA (CABAZITAXEL) KIT [SANOFI-AVENTIS U.S. LLC]13
cabazitaxelACTIVE MOIETY51F690397JJEVTANA (CABAZITAXEL) KIT [SANOFI-AVENTIS U.S. LLC]13
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HJEVTANA (CABAZITAXEL) KIT [SANOFI-AVENTIS U.S. LLC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5824JEVTANA (CABAZITAXEL) KIT [SANOFI-AVENTIS U.S. LLC]25Current NDC, Legacy NDC, 2 package rows20240822_de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001433cabazitaxel 60 MG in 1.5 ML InjectionPSNde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
1376084JEVTANA 60 MG in 1.5 ML InjectionPSNde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
13760841.5 ML cabazitaxel 40 MG/ML Injection [Jevtana]SBDde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
10014331.5 ML cabazitaxel 40 MG/ML InjectionSCDde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
1001433cabazitaxel 40 MG/ML per 1.5 ML InjectionSYde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
1001433cabazitaxel 60 MG per 1.5 ML InjectionSYde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
1376084Jevtana 40 MG/ML per 1.5 ML InjectionSYde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27
1376084Jevtana 60 MG per 1.5 ML InjectionSYde3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5823-15000245823155.7 mL in 1 VIAL, GLASS5.7 mlHistorical
0024-5824-11000245824111 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01) 1 kit2010-06-170000-00-00NoNoCurrent