NDC 58468-0080

Thymoglobulin

Anti-thymocyte Globulin (rabbit)

Thymoglobulin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Lapine T-lymphocyte Immune Globulin.

• Product ID: 58468-0080_3e3b7975-cabd-4b6a-971a-15ca2fc7bb9e
• NDC: 58468-0080
• Product Type: Human Prescription Drug
• Proprietary Name: Thymoglobulin
• Generic Name: Anti-thymocyte Globulin (rabbit)
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1998-12-30
• Marketing Category: BLA / BLA
• Application Number: BLA103869
• Labeler Name: Genzyme Corporation
• Substance Name: LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Immunoglobulin G [EPC],Lymphocyte Function Alteration [PE],Increased T Lymphocyte Destruction [PE],Antibody-Surface Protein Interactions [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58468-0080-1

1 VIAL, GLASS in 1 CARTON (58468-0080-1) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 1998-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0080-1 [58468008001]

Thymoglobulin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103869
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-12-30

Drug Details

Active Ingredients

Ingredient	Strength
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN	5 mg/mL

OpenFDA Data

• SPL SET ID: bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • D7RD81HE4W
• RxNorm Concept Unique ID - RxCUI:
  • 107050
  • 107047

Pharmacological Class

• Immunoglobulin G [EPC]
• Lymphocyte Function Alteration [PE]
• Increased T Lymphocyte Destruction [PE]
• Antibody-Surface Protein Interactions [MoA]
• Immunoglobulins [CS]