TALTZ

Product NDC
0002-8900
11-digit product format
000028900
Labeler code
0002
Product ID
0002-8900_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
20 mg/.25mL
Pharmacologic classes
Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
0002-8900_246fceb3-0f60-4bd7-8f06-4f34537f5d95
SPL ID
246fceb3-0f60-4bd7-8f06-4f34537f5d95
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
TALTZ
Generic name
ixekizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Marketing start
2016-03-22
Marketing category
BLA
Application number
BLA125521
Pharmacologic classes
Interleukin-17A Antagonist [EPC]; Interleukin-17A Antagonists [MoA]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
IXEKIZUMAB20 mg/.25mL

openFDA Harmonized Identifiers

FieldValues
UniiBTY153760O
Rxcui1745103, 1745108, 1745112, 1745114, 2674931, 2674932, 2674933, 2674934
Spl Set Idac96658a-d7dc-4c7c-8928-2adcdf4318b2
Manufacturer NameEli Lilly and Company

openFDA Package Details

Package NDCDescriptionMarketing startSample
0002-8900-111 SYRINGE in 1 CARTON (0002-8900-11) / 1 mL in 1 SYRINGE (0002-8900-01)2024-02-02No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
BTY153760OIXEKIZUMAB1143503-69-8IXEKIZUMAB

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-8900-11000028900111 SYRINGE in 1 CARTON (0002-8900-11) / 1 mL in 1 SYRINGE (0002-8900-01) 1 syringe2024-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TALTZEli Lilly and Company2024-11-13HUMAN PRESCRIPTION DRUG LABEL39