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 Identifiers#

Field, Values table
FieldValues
Unii74T7185BMM
Rxcui2373955, 2373960, 2373966, 2373967

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

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