Starjemza

Product NDC
0143-9168
11-digit product format
001439168
Labeler code
0143
Product ID
0143-9168_4f0ed512-9cd1-4280-af36-37ed3090d632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-hmny
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
BLA761419
Marketing category
BLA
Marketing start
2025-10-27
Substance
USTEKINUMAB
Active strength
45 mg/.5mL
Pharmacologic classes
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
FU77B4U5Z0USTEKINUMAB815610-63-0USTEKINUMAB

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9168-0100143916801.5 mL in 1 SYRINGE (0143-9168-01) 2025-10-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Starjemza - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2025-10-24HUMAN PRESCRIPTION DRUG LABEL5