starjemza

Generic: ustekinumab-hmny

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name starjemza
Generic Name ustekinumab-hmny
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab 45 mg/.5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9168
Product ID 0143-9168_4f0ed512-9cd1-4280-af36-37ed3090d632
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761419
Listing Expiration 2026-12-31
Marketing Start 2025-10-27

Pharmacologic Class

Established (EPC)
interleukin-12 antagonist [epc] interleukin-23 antagonist [epc]
Mechanism of Action
interleukin-12 antagonists [moa] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439168
Hyphenated Format 0143-9168

Supplemental Identifiers

RxCUI
2725087 2725094 2725099 2725100 2725102 2725106 2725111 2725114
UNII
FU77B4U5Z0
NUI
N0000192797 N0000192796 N0000192799 N0000192798

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name starjemza (source: ndc)
Generic Name ustekinumab-hmny (source: ndc)
Application Number BLA761419 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • .5 mL in 1 SYRINGE (0143-9168-01)
source: ndc

Packages (1)

0143-9168-01 .5 mL in 1 SYRINGE (0143-9168-01)

Ingredients (1)

ustekinumab (45 mg/.5mL)

Linked Drug Pages (1)

Starjemza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4f0ed512-9cd1-4280-af36-37ed3090d632", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2725087", "2725094", "2725099", "2725100", "2725102", "2725106", "2725111", "2725114"], "spl_set_id": ["8b72aa27-82cc-4c1b-be43-8b50e5e3d737"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".5 mL in 1 SYRINGE (0143-9168-01)", "package_ndc": "0143-9168-01", "marketing_start_date": "20251027"}], "brand_name": "Starjemza", "product_id": "0143-9168_4f0ed512-9cd1-4280-af36-37ed3090d632", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "0143-9168", "generic_name": "ustekinumab-hmny", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Starjemza", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "45 mg/.5mL"}], "application_number": "BLA761419", "marketing_category": "BLA", "marketing_start_date": "20251027", "listing_expiration_date": "20261231"}