Home NDC 58468-0080 Thymoglobulin
Product NDC 58468-0080
11-digit product format 584680080
Labeler code 58468
Product ID 58468-0080_5c65708a-7f79-4d63-b4a9-b2b1a2d86bdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anti-thymocyte Globulin (Rabbit)
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA103869
Marketing category BLA
Marketing start 1998-12-30
Substance LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN
Active strength 5 mg/mL
Pharmacologic classes Antibody-Surface Protein Interactions [MoA], Immunoglobulin G [EPC], Immunoglobulins [CS], Increased T Lymphocyte Destruction [PE], Lymphocyte Function Alteration [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Thymoglobulin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D7RD81HE4W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 107047 Internal RxNorm lookup 107050 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58468-0080-1 Thymoglobulin 5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 5 21 58468-0080-1 Thymoglobulin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN ACTIVE INGREDIENT D7RD81HE4W THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 9 LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN ACTIVE MOIETY D7RD81HE4W THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 9 GLYCINE INACTIVE INGREDIENT TE7660XO1C THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 9 MANNITOL INACTIVE INGREDIENT 3OWL53L36A THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 9 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0080 THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 18 Current NDC, Legacy NDC, 2 package rows 20241012_bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103869 Thymoglobulin Anti-thymocyte Globulin (Rabbit) 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58468-0080-1 58468008001 1 VIAL, GLASS in 1 CARTON (58468-0080-1) / 5 mL in 1 VIAL, GLASS 1998-12-30 0000-00-00 No No Current