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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72677-551DDiscontinued by firm2026-08-17
excluded packagepackage72677-55172677-551-01DDiscontinued by firm2026-08-17

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

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

Purple Book Biologic Products#

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

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