NDC 71655-103

Raxibacumab

Raxibacumab

Raxibacumab is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Emergent Manufacturing Operations Baltimore Llc. The primary component is Raxibacumab.

• Product ID: 71655-103_8bdc1b76-3c74-4a6a-8a82-86a6a09f6c1d
• NDC: 71655-103
• Product Type: Human Prescription Drug
• Proprietary Name: Raxibacumab
• Generic Name: Raxibacumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-12-14
• Marketing Category: BLA / BLA
• Application Number: BLA125349
• Labeler Name: Emergent Manufacturing Operations Baltimore LLC
• Substance Name: RAXIBACUMAB
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 71655-103-01

1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) > 34 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2012-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71655-103-01 [71655010301]

Raxibacumab INJECTION

• Marketing Category: BLA
• Application Number: BLA125349
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-14

Drug Details

Active Ingredients

Ingredient	Strength
RAXIBACUMAB	50 mg/mL

OpenFDA Data

• SPL SET ID: f6927e91-bb46-47b3-ab66-f9d8a9d7b12a
• Manufacturer:
  • Emergent Manufacturing Operations Baltimore LLC
• UNII:
  • 794PGL549S
• 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"

NDC	Brand Name	Generic Name
49401-103	Raxibacumab	raxibacumab
71655-103	Raxibacumab	raxibacumab