Home NDC 58468-0070 ALDURAZYME
Product NDC 58468-0070
11-digit product format 584680070
Labeler code 58468
Product ID 58468-0070_a6819483-3275-4b44-8e87-f6246503af43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name laronidase
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA125058
Marketing category BLA
Marketing start 2003-04-30
Substance LARONIDASE
Active strength 2.9 mg/5mL
Pharmacologic classes Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ALDURAZYME
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LARONIDASE 2.9 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WP58SVM6R4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403822 Internal RxNorm lookup 404492 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 58468-0070-1 ALDURAZYME 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 5 37
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LARONIDASE ACTIVE INGREDIENT WP58SVM6R4 ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11 LARONIDASE ACTIVE MOIETY WP58SVM6R4 ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0070 ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 36 Current NDC, Legacy NDC, 1 package rows 20241010_a80ac249-cae4-41f3-88bb-344088b20e60.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 125058 Aldurazyme laronidase 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 58468-0070-1 58468007001 5 mL in 1 VIAL, GLASS (58468-0070-1) 5 ml 2003-04-30 0000-00-00 No No Current