NDC 49401-103

Raxibacumab

Raxibacumab

Raxibacumab is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Human Genome Sciences, Inc.. The primary component is Raxibacumab.

Product ID49401-103_7ca23f5f-4c47-4280-a2e8-433b69e1f5cc
NDC49401-103
Product TypeHuman Prescription Drug
Proprietary NameRaxibacumab
Generic NameRaxibacumab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-12-14
Marketing End Date2022-05-31
Marketing CategoryBLA / BLA
Application NumberBLA125349
Labeler NameHuman Genome Sciences, Inc.
Substance NameRAXIBACUMAB
Active Ingredient Strength50 mg/mL
Pharm ClassesAnthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA]
NDC Exclude FlagN

Packaging

NDC 49401-103-01

1 VIAL, SINGLE-USE in 1 CARTON (49401-103-01) > 34 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2012-12-14
Marketing End Date2022-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49401-103-01 [49401010301]

Raxibacumab INJECTION
Marketing CategoryBLA
Application NumberBLA125349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-14
Marketing End Date2022-05-31

Drug Details

Active Ingredients

IngredientStrength
RAXIBACUMAB50 mg/mL

OpenFDA Data

SPL SET ID:a79c6f44-e978-44c3-b843-69793b03e830
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1366571
  • Pharmacological Class

    • Anthrax Protective Antigen-directed Antibody [EPC]
    • Anthrax Protective Antigen-directed Antibody Interactions [MoA]
    • Anthrax Protective Antigen-directed Antibody [EPC]
    • Anthrax Protective Antigen-directed Antibody Interactions [MoA]

    NDC Crossover Matching brand name "Raxibacumab" or generic name "Raxibacumab"

    NDCBrand NameGeneric Name
    49401-103Raxibacumabraxibacumab
    71655-103Raxibacumabraxibacumab

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