Drug class · Oncology & immunology

Monoclonal antibodies Drug Codes & NDCs

Products the FDA listing tags with the monoclonal-antibody chemical structure class, plus the PD-1, PD-L1 and CD20 antibody classes. Not every antibody product carries these tags, so treat this list as a starting point rather than a complete census.

111 finished products listed with the FDA

FDA-listed products

Finished products in the Monoclonal antibodies class, A–Z by brand
ProductStrengthForm · routeLabelerProduct NDC
PraluentalirocumabAlirocumab 75 mg/mLInjection, SolutionSubcutaneousRegeneron Pharmaceuticals, Inc.61755-020
PraluentalirocumabAlirocumab 150 mg/mLInjection, SolutionSubcutaneousRegeneron Pharmaceuticals, Inc.61755-021
RepathaevolocumabEvolocumab 140 mg/mLInjection, SolutionSubcutaneousAmgen USA Inc.72511-143
RepathaevolocumabEvolocumab 140 mg/mLInjection, SolutionSubcutaneousAmgen USA Inc.72511-393
RepathaevolocumabEvolocumab 140 mg/mLInjection, SolutionSubcutaneousAmgen USA Inc.72511-501
RepathaevolocumabEvolocumab 140 mg/mLInjection, SolutionSubcutaneousAmgen USA Inc.72511-750
RepathaevolocumabEvolocumab 140 mg/mLInjection, SolutionSubcutaneousAmgen USA Inc.72511-760
Riabnirituximab-arrxRituximab 100 mg/10mLInjection, SolutionIntravenousAmgen, Inc55513-224
Riabnirituximab-arrxRituximab 500 mg/50mLInjection, SolutionIntravenousAmgen, Inc55513-326
RituxanrituximabRituximab 10 mg/mLInjection, SolutionIntravenousGenentech, Inc.50242-051
RituxanrituximabRituximab 10 mg/mLInjection, SolutionIntravenousGenentech, Inc.50242-053
Rituxan Hycelarituximab and hyaluronidaseRituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mLInjection, SolutionSubcutaneousGenentech, Inc.50242-108
Rituxan Hycelarituximab and hyaluronidaseRituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mLInjection, SolutionSubcutaneousGenentech, Inc.50242-109
Ruxiencerituximab-pvvrRituximab 100 mg/10mLInjection, SolutionIntravenousPfizer Laboratories Div Pfizer Inc0069-0238
Ruxiencerituximab-pvvrRituximab 500 mg/50mLInjection, SolutionIntravenousPfizer Laboratories Div Pfizer Inc0069-0249
SarclisaisatuximabIsatuximab 100 mg/5mLInjection, Solution, ConcentrateIntravenousSanofi-Aventis U.S. LLC0024-0654
SarclisaisatuximabIsatuximab 500 mg/25mLInjection, Solution, ConcentrateIntravenousSanofi-Aventis U.S. LLC0024-0656
Sarclisa Escenaisatuximab-irfcIsatuximab 140 mg/mLInjection, SolutionSubcutaneousSanofi-Aventis U.S. LLC0024-0674
SiliqbrodalumabBrodalumab 210 mg/1InjectionSubcutaneousBausch Health US LLC0187-0004
TecentriqatezolizumabAtezolizumab 1200 mg/20mLInjection, SolutionIntravenousGenentech, Inc.50242-917
TecentriqatezolizumabAtezolizumab 840 mg/14mLInjection, SolutionIntravenousGenentech, Inc.50242-918
Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjsAtezolizumab 1875 mg/15mL; Hyaluronidase (Human recombinant) 30000 U/15mLInjectionSubcutaneousGenentech, Inc.50242-933
Tevimbratislelizumab-jsgrTislelizumab 10 mg/mLInjection, Solution, ConcentrateIntravenousBeOne Medicines USA, Inc.72579-121
Tevimbratislelizumab-jsgrTislelizumab 10 mg/mLInjection, Solution, ConcentrateIntravenousBeOne Medicines USA, Inc.72579-125
Truximarituximab-abbsRituximab 10 mg/mLInjection, SolutionIntravenousCephalon, Inc.63459-103

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