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 Identifiers# Field, Values table Field Values Unii D7RD81HE4W Rxcui 107047, 107050
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
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