Home NDC 58468-0426 Nexviazyme
Product NDC 58468-0426
11-digit product format 584680426
Labeler code 58468
Product ID 58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name avalglucosidase alfa-ngpt
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA761194
Marketing category BLA
Marketing start 2021-08-06
Substance AVALGLUCOSIDASE ALFA
Active strength 100 mg/10mL
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 Additional Listing Data#
Finished product Yes
Brand name base Nexviazyme
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVALGLUCOSIDASE ALFA 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EO144CP0X9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2565818 Internal RxNorm lookup 2565823 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 58468-0426-1 Nexviazyme 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 4 58468-0426-1 Nexviazyme 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0426 NEXVIAZYME NGPT (AVALGLUCOSIDASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20230927_80eb3c9c-01d3-44fe-90ef-81df101b954d.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 761194 Nexviazyme avalglucosidase alfa-ngpt 351(a) Rx 2026-07-01
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 58468-0426-1 58468042601 1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSE 2021-08-06 0000-00-00 No No Current