Home NDC 58468-0160-2 Lumizyme
Product NDC 58468-0160
Requested package NDC 58468-0160-2
11-digit product format 584680160
Labeler code 58468
Product ID 58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALGLUCOSIDASE ALFA
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA125291
Marketing category BLA
Marketing start 2010-05-24
Substance ALGLUCOSIDASE ALFA
Active strength 5 mg/mL
Pharmacologic classes Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Additional Listing Data#
Finished product Yes
Brand name base Lumizyme
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALGLUCOSIDASE ALFA 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DTI67O9503 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 629568 Internal RxNorm lookup 993072 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58468-0160-1 Lumizyme 10.5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 10.5 21 58468-0160-1 Lumizyme 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 21 58468-0160-2 Lumizyme 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 21 58468-0160-2 Lumizyme 10.5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 10.5 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALGLUCOSIDASE ALFA ACTIVE INGREDIENT DTI67O9503 LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8 ALGLUCOSIDASE ALFA ACTIVE MOIETY DTI67O9503 LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0160 LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] 21 Current NDC, Legacy NDC, 4 package rows 20250112_d6bfbc45-2d34-439e-8aad-59ee2d53d4df.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 125291 Lumizyme alglucosidase alfa 351(a) Rx 2026-06-01
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 58468-0160-2 58468016002 10 VIAL, SINGLE-USE in 1 CARTON (58468-0160-2) > 10.5 mL in 1 VIAL, SINGLE-USE 2010-05-24 2023-08-31 No No Current