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
BriumviublituximabUblituximab 150 mg/6mLInjection, Solution, ConcentrateIntravenousTG Therapeutics, Inc.73150-150
DarzalexdaratumumabDaratumumab 100 mg/5mLInjection, Solution, ConcentrateIntravenousJanssen Biotech, Inc.57894-502
Darzalex Fasprodaratumumab and hyaluronidase-fihj (human recombinant)Daratumumab 1800 mg/15mL; Hyaluronidase (Human recombinant) 30000 U/15mLInjectionSubcutaneousJanssen Biotech, Inc.57894-503
Darzalex IVdaratumumabDaratumumab 100 mg/5mLInjection, Solution, ConcentrateIntravenousJanssen Biotech, Inc.57894-505
DupixentdupilumabDupilumab 300 mg/2mLInjection, SolutionSubcutaneousSanofi-Aventis U.S. LLC0024-5914
DupixentdupilumabDupilumab 300 mg/2mLInjection, SolutionSubcutaneousSanofi-Aventis U.S. LLC0024-5915
DupixentdupilumabDupilumab 200 mg/1.14mLInjection, SolutionSubcutaneousSanofi-Aventis U.S. LLC0024-5918
DupixentdupilumabDupilumab 200 mg/1.14mLInjection, SolutionSubcutaneousSanofi-Aventis U.S. LLC0024-5919
EmplicitielotuzumabElotuzumab 300 mg/1Injection, Powder, Lyophilized, For solutionIntravenousE.R. Squibb & Sons, L.L.C.0003-2291
EmplicitielotuzumabElotuzumab 400 mg/1Injection, Powder, Lyophilized, For solutionIntravenousE.R. Squibb & Sons, L.L.C.0003-4522
GazyvaobinutuzumabObinutuzumab 1000 mg/40mLInjection, Solution, ConcentrateIntravenousGenentech, Inc.50242-070
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousA-S Medication Solutions50090-6705
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousA-S Medication Solutions50090-6706
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousA-S Medication Solutions50090-6707
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-183
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-184
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.8mLSolutionSubcutaneousOrganon LLC78206-185
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-186
Hadlimaadalimumab-bwwdAdalimumab 40 mg/.4mLSolutionSubcutaneousOrganon LLC78206-187
Hyrimozadalimumab-adazAdalimumab 80 mg/.8mLInjection, SolutionSubcutaneousSandoz Inc61314-454
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousSandoz Inc61314-473
Hyrimozadalimumab-adazAdalimumab 20 mg/.2mLInjection, SolutionSubcutaneousSandoz Inc61314-476
Hyrimozadalimumab-adazAdalimumab 10 mg/.1mLInjection, SolutionSubcutaneousSandoz Inc61314-509
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousCordavis Limited83457-100
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousCordavis Limited83457-101

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