voraxaze

Generic: glucarpidase

Labeler: btg international inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name voraxaze
Generic Name glucarpidase
Labeler btg international inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

glucarpidase 1000 [USP'U]/1

Manufacturer
BTG International Inc.

Identifiers & Regulatory

Product NDC 50633-210
Product ID 50633-210_27e39e9a-42e0-fb03-e063-6394a90aae3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125327
Listing Expiration 2026-12-31
Marketing Start 2012-04-01

Pharmacologic Class

Established (EPC)
carboxypeptidase [epc]
Chemical Structure
carboxypeptidases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50633210
Hyphenated Format 50633-210

Supplemental Identifiers

RxCUI
1242131 1242136
UNII
2GFP9BJD79
NUI
N0000184013 M0003411

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name voraxaze (source: ndc)
Generic Name glucarpidase (source: ndc)
Application Number BLA125327 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

50633-210-11 1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (1)

glucarpidase (1000 [USP'U]/1)

Linked Drug Pages (1)

Voraxaze ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "27e39e9a-42e0-fb03-e063-6394a90aae3e", "openfda": {"nui": ["N0000184013", "M0003411"], "unii": ["2GFP9BJD79"], "rxcui": ["1242131", "1242136"], "spl_set_id": ["acaef5a6-b740-40e3-8ffe-74a75c74745c"], "pharm_class_cs": ["Carboxypeptidases [CS]"], "pharm_class_epc": ["Carboxypeptidase [EPC]"], "manufacturer_name": ["BTG International Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (50633-210-11)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "50633-210-11", "marketing_start_date": "20120401"}], "brand_name": "Voraxaze", "product_id": "50633-210_27e39e9a-42e0-fb03-e063-6394a90aae3e", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carboxypeptidase [EPC]", "Carboxypeptidases [CS]"], "product_ndc": "50633-210", "generic_name": "glucarpidase", "labeler_name": "BTG International Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voraxaze", "active_ingredients": [{"name": "GLUCARPIDASE", "strength": "1000 [USP'U]/1"}], "application_number": "BLA125327", "marketing_category": "BLA", "marketing_start_date": "20120401", "listing_expiration_date": "20261231"}