uplizna

Generic: inebilizumab

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name uplizna
Generic Name inebilizumab
Labeler horizon therapeutics usa, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

inebilizumab 10 mg/mL

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-150
Product ID 75987-150_ec8e46bc-7edf-405d-8c8e-2b2f7042fcb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761142
Listing Expiration 2026-12-31
Marketing Start 2020-06-11

Pharmacologic Class

Established (EPC)
cd19-directed cytolytic antibody [epc]
Mechanism of Action
cd19-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987150
Hyphenated Format 75987-150

Supplemental Identifiers

RxCUI
2373955 2373960 2373966 2373967
UPC
0375987150032
UNII
74T7185BMM
NUI
N0000194013 N0000191422

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 uplizna (source: ndc)
Generic Name inebilizumab (source: ndc)
Application Number BLA761142 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01)
source: ndc

Packages (1)

75987-150-03 3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01)

Ingredients (1)

inebilizumab (10 mg/mL)

Linked Drug Pages (1)

UPLIZNA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ec8e46bc-7edf-405d-8c8e-2b2f7042fcb5", "openfda": {"nui": ["N0000194013", "N0000191422"], "upc": ["0375987150032"], "unii": ["74T7185BMM"], "rxcui": ["2373955", "2373960", "2373966", "2373967"], "spl_set_id": ["834db232-afb0-4dcf-93e0-009ce8245c20"], "pharm_class_epc": ["CD19-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD19-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03)  / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01)", "package_ndc": "75987-150-03", "marketing_start_date": "20200611"}], "brand_name": "UPLIZNA", "product_id": "75987-150_ec8e46bc-7edf-405d-8c8e-2b2f7042fcb5", "dosage_form": "INJECTION", "pharm_class": ["CD19-directed Antibody Interactions [MoA]", "CD19-directed Cytolytic Antibody [EPC]"], "product_ndc": "75987-150", "generic_name": "Inebilizumab", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UPLIZNA", "active_ingredients": [{"name": "INEBILIZUMAB", "strength": "10 mg/mL"}], "application_number": "BLA761142", "marketing_category": "BLA", "marketing_start_date": "20200611", "listing_expiration_date": "20261231"}