thymoglobulin

Generic: anti-thymocyte globulin (rabbit)

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name thymoglobulin
Generic Name anti-thymocyte globulin (rabbit)
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lapine t-lymphocyte immune globulin 5 mg/mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0080
Product ID 58468-0080_5c65708a-7f79-4d63-b4a9-b2b1a2d86bdd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103869
Listing Expiration 2027-12-31
Marketing Start 1998-12-30

Pharmacologic Class

Established (EPC)
immunoglobulin g [epc]
Mechanism of Action
antibody-surface protein interactions [moa]
Chemical Structure
immunoglobulins [cs]
Physiologic Effect
lymphocyte function alteration [pe] increased t lymphocyte destruction [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680080
Hyphenated Format 58468-0080

Supplemental Identifiers

RxCUI
107047 107050
UNII
D7RD81HE4W
NUI
N0000184163 N0000178327 N0000009689 N0000020023 M0011122

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name thymoglobulin (source: ndc)
Generic Name anti-thymocyte globulin (rabbit) (source: ndc)
Application Number BLA103869 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (58468-0080-1) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

lapine t-lymphocyte immune globulin (5 mg/mL)

Linked Drug Pages (1)

Thymoglobulin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5c65708a-7f79-4d63-b4a9-b2b1a2d86bdd", "openfda": {"nui": ["N0000184163", "N0000178327", "N0000009689", "N0000020023", "M0011122"], "unii": ["D7RD81HE4W"], "rxcui": ["107047", "107050"], "spl_set_id": ["bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae"], "pharm_class_cs": ["Immunoglobulins [CS]"], "pharm_class_pe": ["Lymphocyte Function Alteration [PE]", "Increased T Lymphocyte Destruction [PE]"], "pharm_class_epc": ["Immunoglobulin G [EPC]"], "pharm_class_moa": ["Antibody-Surface Protein Interactions [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (58468-0080-1)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "58468-0080-1", "marketing_start_date": "19981230"}], "brand_name": "Thymoglobulin", "product_id": "58468-0080_5c65708a-7f79-4d63-b4a9-b2b1a2d86bdd", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antibody-Surface Protein Interactions [MoA]", "Immunoglobulin G [EPC]", "Immunoglobulins [CS]", "Increased T Lymphocyte Destruction [PE]", "Lymphocyte Function Alteration [PE]"], "product_ndc": "58468-0080", "generic_name": "Anti-thymocyte Globulin (Rabbit)", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thymoglobulin", "active_ingredients": [{"name": "LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN", "strength": "5 mg/mL"}], "application_number": "BLA103869", "marketing_category": "BLA", "marketing_start_date": "19981230", "listing_expiration_date": "20271231"}