NDC 69604-204

Anthim

Obiltoxaximab

Anthim is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Elusys Therapeutics, Inc.. The primary component is Obiltoxaximab.

• Product ID: 69604-204_6ff70900-99e5-11e6-bdf4-0800200c9a66
• NDC: 69604-204
• Product Type: Human Prescription Drug
• Proprietary Name: Anthim
• Generic Name: Obiltoxaximab
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-03-18
• Marketing Category: BLA / BLA
• Application Number: BLA125509
• Labeler Name: Elusys Therapeutics, Inc.
• Substance Name: OBILTOXAXIMAB
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69604-204-02

1 VIAL, SINGLE-USE in 1 CARTON (69604-204-02) > 6 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-03-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69604-204-02 [69604020402]

Anthim SOLUTION

• Marketing Category: BLA
• Application Number: BLA125509
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-18

Drug Details

Active Ingredients

Ingredient	Strength
OBILTOXAXIMAB	100 mg/mL

OpenFDA Data

• SPL SET ID: 39ad8799-00a4-4fc8-9852-c0536350c474
• Manufacturer:
  • Elusys Therapeutics, Inc.
• UNII:
  • 29Z5DNL48C
• RxNorm Concept Unique ID - RxCUI:
  • 1746915
  • 1746910

Pharmacological Class

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