FDA.reportPublic FDA data

TALTZ

Product NDC
0002-1445
11-digit product format
000021445
Labeler code
0002
Product ID
0002-1445_246fceb3-0f60-4bd7-8f06-4f34537f5d95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ixekizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA125521
Marketing category
BLA
Marketing start
2016-03-22
Substance
IXEKIZUMAB
Active strength
80 mg/mL
Pharmacologic classes
Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TALTZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IXEKIZUMAB80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBTY153760O
Rxcui1745103, 1745108, 1745112, 1745114, 2674931, 2674932, 2674933, 2674934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
db229e93-3aa5-4b93-8717-2812d595ac27Product name120160504

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-1445-01TALTZ1 mL in 1 SYRINGEINJECTION, SOLUTION139
0002-1445-09TALTZ3 in 1 CARTONINJECTION, SOLUTION339
0002-1445-11TALTZ1 in 1 CARTONINJECTION, SOLUTION139
0002-1445-27TALTZ2 in 1 CARTONINJECTION, SOLUTION239
0002-1445-61TALTZ1 mL in 1 SYRINGEINJECTION, SOLUTION139
0002-1445-61TALTZ1 in 1 CARTONINJECTION, SOLUTION139

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-1445-01ML - Milliliter0002-14454940542e-e24b-4d19-9204-6befc8b2775c12016-05-16
0002-1445-09ML - Milliliter0002-1445e986dcb5-2f7a-451c-8854-3587f24b592012016-04-04
0002-1445-11ML - Milliliter0002-14451fa3bce2-9c6f-4bd0-9df8-86bc311149a112016-04-04
0002-1445-27ML - Milliliter0002-1445545c5940-7abc-49ba-87ad-d8095edab4f212016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-1445TALTZ (IXEKIZUMAB) INJECTION, SOLUTION [ELI LILLY AND COMPANY]39Current NDC, Legacy NDC, 6 package rows20241220_ac96658a-d7dc-4c7c-8928-2adcdf4318b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2674931ixekizumab 20 MG in 0.25 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674933ixekizumab 40 MG in 0.5 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745103ixekizumab 80 MG in 1 ML Auto-InjectorPSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745112ixekizumab 80 MG in 1 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674932taltz 20 MG in 0.25 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674934taltz 40 MG in 0.5 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745108taltz 80 MG in 1 ML Auto-InjectorPSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745114taltz 80 MG in 1 ML Prefilled SyringePSNac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749320.25 ML ixekizumab 80 MG/ML Prefilled Syringe [Taltz]SBDac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749340.5 ML ixekizumab 80 MG/ML Prefilled Syringe [Taltz]SBDac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451081 ML ixekizumab 80 MG/ML Auto-Injector [Taltz]SBDac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451141 ML ixekizumab 80 MG/ML Prefilled Syringe [Taltz]SBDac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749310.25 ML ixekizumab 80 MG/ML Prefilled SyringeSCDac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749330.5 ML ixekizumab 80 MG/ML Prefilled SyringeSCDac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451031 ML ixekizumab 80 MG/ML Auto-InjectorSCDac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451121 ML ixekizumab 80 MG/ML Prefilled SyringeSCDac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749320.25 ML Taltz 80 MG/ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
26749340.5 ML Taltz 80 MG/ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451081 ML Taltz 80 MG/ML Auto-InjectorSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
17451141 ML Taltz 80 MG/ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674931ixekizumab 20 MG per 0.25 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674933ixekizumab 40 MG per 0.5 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745103ixekizumab 80 MG per 1 ML Auto-InjectorSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745112ixekizumab 80 MG per 1 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674932Taltz 20 MG per 0.25 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
2674934Taltz 40 MG per 0.5 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745108Taltz 80 MG per 1 ML Auto-InjectorSYac96658a-d7dc-4c7c-8928-2adcdf4318b239
1745114Taltz 80 MG per 1 ML Prefilled SyringeSYac96658a-d7dc-4c7c-8928-2adcdf4318b239

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-1445-01000021445011 mL in 1 SYRINGE1 mlHistorical
0002-1445-09000021445093 SYRINGE in 1 CARTON (0002-1445-09) / 1 mL in 1 SYRINGE (0002-1445-01) 3 syringe2016-03-220000-00-00NoNoCurrent
0002-1445-11000021445111 SYRINGE in 1 CARTON (0002-1445-11) / 1 mL in 1 SYRINGE (0002-1445-01) 1 syringe2016-03-220000-00-00NoNoCurrent
0002-1445-27000021445272 SYRINGE in 1 CARTON (0002-1445-27) / 1 mL in 1 SYRINGE (0002-1445-01) 2 syringe2016-03-220000-00-00NoNoCurrent
0002-1445-61000021445611 SYRINGE in 1 CARTON (0002-1445-61) / 1 mL in 1 SYRINGE1 syringe2016-04-190000-00-00YesNoCurrent