NDC 0069-0249

Ruxience

Rituximab-pvvr

Ruxience is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Rituximab.

Product ID0069-0249_a088d7a9-1427-41af-9c9e-5d69a7ac91c5
NDC0069-0249
Product TypeHuman Prescription Drug
Proprietary NameRuxience
Generic NameRituximab-pvvr
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-23
Marketing CategoryBLA /
Application NumberBLA761103
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameRITUXIMAB
Active Ingredient Strength500 mg/50mL
Pharm ClassesCD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-0249-01

1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) > 50 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-01-23
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Ruxience" or generic name "Rituximab-pvvr"

NDCBrand NameGeneric Name
0069-0238Ruxiencerituximab-pvvr
0069-0249Ruxiencerituximab-pvvr

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.