FDA.reportPublic FDA data

UPLIZNA

Product NDC
72677-551
11-digit product format
726770551
Labeler code
72677
Product ID
72677-551_7edce787-91e3-4b7d-9800-66711a5c096f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Inebilizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Viela Bio, Inc.
Application
BLA761142
Marketing category
BLA
Marketing start
2020-06-11
Marketing end
0000-00-00
Substance
INEBILIZUMAB
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72677-551DDiscontinued by firm2026-07-31
excluded packagepackage72677-55172677-551-01DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72677-551-01ML - Milliliter72677-5512789cd5c-f8a5-4dc4-b920-84d8a226e21c12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72677-551UPLIZNA (INEBILIZUMAB) INJECTION [VIELA BIO, INC.]9Legacy NDC20221221_0ce5e7f6-eb97-4738-8b10-43b89e16b5b3.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761142Upliznainebilizumab-cdon351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72677-551-01726770551013 VIAL, SINGLE-DOSE in 1 CARTON (72677-551-01) > 10 mL in 1 VIAL, SINGLE-DOSE (72677-551-03) 2020-06-110000-00-00NoNoCurrent