Home NDC 50633-210 Voraxaze
Product NDC 50633-210
11-digit product format 506330210
Labeler code 50633
Product ID 50633-210_27e39e9a-42e0-fb03-e063-6394a90aae3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glucarpidase
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler BTG International Inc.
Application BLA125327
Marketing category BLA
Marketing start 2012-04-01
Substance GLUCARPIDASE
Active strength 1000 [USP'U]/1
Pharmacologic classes Carboxypeptidase [EPC], Carboxypeptidases [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Voraxaze
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLUCARPIDASE 1000 [USP'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2GFP9BJD79 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1242131 Internal RxNorm lookup 1242136 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 50633-210-11 Voraxaze 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 10 50633-210-11 Voraxaze 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLUCARPIDASE ACTIVE INGREDIENT 2GFP9BJD79 VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 5 GLUCARPIDASE ACTIVE MOIETY 2GFP9BJD79 VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 5 TROMETHAMINE HYDROCHLORIDE INACTIVE INGREDIENT 383V75M34E VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 5 ZINC ACETATE INACTIVE INGREDIENT FM5526K07A VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50633-210 VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241128_acaef5a6-b740-40e3-8ffe-74a75c74745c.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 125327 Voraxaze glucarpidase 351(a) Rx 2026-06-01
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 50633-210-11 50633021011 1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 1 vial 2012-04-01 0000-00-00 No No Current