Home NDC 58468-1849 Thyrogen
Product NDC 58468-1849
11-digit product format 584681849
Labeler code 58468
Product ID 58468-1849_6887abed-9473-4463-9c37-b4832668de6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name THYROTROPIN ALFA
Dosage form KIT
Labeler Genzyme Corporation
Application NDA020898
Marketing category NDA
Marketing start 1998-11-30
Marketing end 2019-05-30
Active strength 0
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58468-1849-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58468-1849-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58468-1849-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58468-1849-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58468-1849-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58468-1849-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58468-1849-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58468-1849-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58468-1849-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58468-1849-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58468-1849-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58468-1849-4 557ba5c1ecfa…9c80585c8c6e…
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58468-1849-4 Thyrogen 1 in 1 CARTON KIT 1 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 58468-1849 THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] 20 Legacy NDC, 1 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 58468-1849-4 58468184904 1 in 1 CARTON Historical