FDA.reportPublic FDA data

UPLIZNA

Product NDC
75987-150
11-digit product format
759870150
Labeler code
75987
Product ID
75987-150_ec8e46bc-7edf-405d-8c8e-2b2f7042fcb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Inebilizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Horizon Therapeutics USA, Inc.
Application
BLA761142
Marketing category
BLA
Marketing start
2020-06-11
Substance
INEBILIZUMAB
Active strength
10 mg/mL
Pharmacologic classes
CD19-directed Antibody Interactions [MoA], CD19-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UPLIZNA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INEBILIZUMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
74T7185BMMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2373955Internal RxNorm lookup
2373960Internal RxNorm lookup
2373966Internal RxNorm lookup
2373967Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834db232-afb0-4dcf-93e0-009ce8245c20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aa730977-6115-43ea-a949-61470ec62e46Product name120200612
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75987-150-01UPLIZNA10 mL in 1 VIAL, SINGLE-DOSEINJECTION109
75987-150-03UPLIZNA3 in 1 CARTONINJECTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-150-01ML - Milliliter75987-15040e5adf5-87ec-4cc9-8e5c-ef9a4c643cdb12022-06-06
75987-150-03ML - Milliliter75987-150c8c95bed-48ce-4e63-b8cf-c4a847a2a85f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-150UPLIZNA (INEBILIZUMAB) INJECTION [HORIZON THERAPEUTICS USA, INC.]7Current NDC, Legacy NDC, 2 package rows20250418_834db232-afb0-4dcf-93e0-009ce8245c20.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UPLIZNAINEBILIZUMABHorizon Therapeutics USA, Inc.834db232-afb0-4dcf-93e0-009ce8245c202025-12-11Warnings, Adverse reactionsExact identifier
application number: BLA761142
ndc (product): 75987-150

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761142Upliznainebilizumab-cdon351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2373967{3 (10 ML inebilizumab-cdon 10 MG/ML Injection [Uplizna]) } Pack [Uplizna 3 Vial Kit]BPCK834db232-afb0-4dcf-93e0-009ce8245c209
2373966{3 (10 ML inebilizumab-cdon 10 MG/ML Injection) } PackGPCK834db232-afb0-4dcf-93e0-009ce8245c209
2373966inebilizumab-cdon 100 MG in 10 ML (3) Injection KitPSN834db232-afb0-4dcf-93e0-009ce8245c209
2373955inebilizumab-cdon 100 MG in 10 ML InjectionPSN834db232-afb0-4dcf-93e0-009ce8245c209
2373960UPLIZNA 100 MG in10 ML InjectionPSN834db232-afb0-4dcf-93e0-009ce8245c209
2373967UPLIZNA 3 Vial KitPSN834db232-afb0-4dcf-93e0-009ce8245c209
237396010 ML inebilizumab-cdon 10 MG/ML Injection [Uplizna]SBD834db232-afb0-4dcf-93e0-009ce8245c209
237395510 ML inebilizumab-cdon 10 MG/ML InjectionSCD834db232-afb0-4dcf-93e0-009ce8245c209
237396010 ML Uplizna 10 MG/ML InjectionSY834db232-afb0-4dcf-93e0-009ce8245c209
2373966inebilizumab-cdon 10 MG/ML per 10 ML (3) Injection PackSY834db232-afb0-4dcf-93e0-009ce8245c209
2373966inebilizumab-cdon 100 MG per 10 ML (3) Injection KitSY834db232-afb0-4dcf-93e0-009ce8245c209
2373955inebilizumab-cdon 100 MG per 10 ML InjectionSY834db232-afb0-4dcf-93e0-009ce8245c209
2373960UPLIZNA 100 MG per 10 ML InjectionSY834db232-afb0-4dcf-93e0-009ce8245c209
2373967Uplizna 3 Vial KitSY834db232-afb0-4dcf-93e0-009ce8245c209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-150-017598701500110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
75987-150-03759870150033 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01) 2020-06-110000-00-00NoNoCurrent