Starjemza

Product NDC
0143-9169
11-digit product format
001439169
Labeler code
0143
Product ID
0143-9169_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
0143-9169-0100143916901.5 mL in 1 VIAL (0143-9169-01) 2025-10-27NoNoHistorical

Related DailyMed Labels

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