NDC 0078-0393

Simulect

Basiliximab

Simulect is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Basiliximab.

• Product ID: 0078-0393_0673b70a-a94f-4a8b-8153-1402e33fa3e0
• NDC: 0078-0393
• Product Type: Human Prescription Drug
• Proprietary Name: Simulect
• Generic Name: Basiliximab
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1998-05-12
• Marketing Category: BLA / BLA
• Application Number: BLA103764
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: BASILIXIMAB
• Active Ingredient Strength: 10 mg/2.5mL
• Pharm Classes: Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0078-0393-61

1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) > 2.5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1998-05-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0393-61 [00078039361]

Simulect INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103764
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-05-12

Drug Details

Active Ingredients

Ingredient	Strength
BASILIXIMAB	10 mg/2.5mL

OpenFDA Data

• SPL SET ID: 1af01887-b69d-444b-91ed-ebfe12784440
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 9927MT646M
• RxNorm Concept Unique ID - RxCUI:
  • 1656650
  • 1656646
  • 1656648
  • 1656643

Pharmacological Class

• Interleukin 2 Receptor Antagonists [MoA]
• Interleukin 2 Receptor-directed Antibody Interactions [MoA]
• Interleukin-2 Receptor Blocking Antibody [EPC]

NDC Crossover Matching brand name "Simulect" or generic name "Basiliximab"

NDC	Brand Name	Generic Name
0078-0331	Simulect	basiliximab
0078-0393	Simulect	basiliximab