NDC 72677-551

UPLIZNA

Inebilizumab

UPLIZNA is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Viela Bio, Inc.. The primary component is Inebilizumab.

Product ID72677-551_2b9d1b79-50d5-438b-8161-2e3c6722d83a
NDC72677-551
Product TypeHuman Prescription Drug
Proprietary NameUPLIZNA
Generic NameInebilizumab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-03-02
Marketing CategoryBLA / BLA
Application NumberBLA761142
Labeler NameViela Bio, Inc.
Substance NameINEBILIZUMAB
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72677-551-01

3 VIAL, SINGLE-DOSE in 1 CARTON (72677-551-01) > 10 mL in 1 VIAL, SINGLE-DOSE (72677-551-03)
Marketing Start Date2020-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72677-551-01 [72677055101]

UPLIZNA INJECTION
Marketing CategoryBLA
Application NumberBLA761142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-02

Drug Details

Active Ingredients

IngredientStrength
INEBILIZUMAB10 mg/mL

NDC Crossover Matching brand name "UPLIZNA" or generic name "Inebilizumab"

NDCBrand NameGeneric Name
72677-551UPLIZNAInebilizumab
75987-150UPLIZNAInebilizumab

Trademark Results [UPLIZNA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UPLIZNA
UPLIZNA
88045691 not registered Live/Pending
VIELA BIO, INC.
2018-07-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.