Ustekinumab-aekn

Product NDC
51759-710
11-digit product format
517590710
Labeler code
51759
Product ID
51759-710_1577b43b-65ee-4da4-9821-338d1651d3d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-aekn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761343
Marketing category
BLA
Marketing start
2025-06-02
Substance
USTEKINUMAB-AEKN
Active strength
90 mg/mL
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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51759-710-32517590710321 TRAY in 1 CARTON (51759-710-32) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS1 tray2025-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ustekinumab-aeknTeva Pharmaceuticals USA, Inc.2025-12-03HUMAN PRESCRIPTION DRUG LABEL9