Home NDC 58468-0030 Thyrogen
Product NDC 58468-0030
11-digit product format 584680030
Labeler code 58468
Product ID 58468-0030_a62de867-ea60-47eb-873a-788223a1181f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name THYROTROPIN ALFA
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Genzyme Corporation
Application BLA020898
Marketing category BLA
Marketing start 1998-11-30
Substance THYROTROPIN ALFA
Active strength .9 mg/mL
Pharmacologic classes Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Thyrogen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THYROTROPIN ALFA .9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AVX3D5A4LM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2166572 Internal RxNorm lookup 2166573 Internal RxNorm lookup 2166578 Internal RxNorm lookup 2166579 Internal RxNorm lookup 2554801 Internal RxNorm lookup 2554802 Internal RxNorm lookup 2554804 Internal RxNorm lookup 2554805 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58468-0030-1 Thyrogen 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 20 58468-0030-2 Thyrogen 2 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 2 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded THYROTROPIN ALFA ACTIVE INGREDIENT AVX3D5A4LM THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12 THYROTROPIN ALFA ACTIVE MOIETY AVX3D5A4LM THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12 SODIUM PHOSPHATE INACTIVE INGREDIENT SE337SVY37 THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12 WATER INACTIVE INGREDIENT 059QF0KO0R THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0030 THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 20 Current NDC, Legacy NDC, 2 package rows 20230306_b52dfa36-f90b-4e19-9b5e-26db9d04df2b.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 020898 Thyrogen thyrotropin alfa 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58468-0030-1 58468003001 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 58468-0030-2 58468003002 2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1) 1998-11-30 0000-00-00 No No Current