nexviazyme

Generic: avalglucosidase alfa-ngpt

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name nexviazyme
Generic Name avalglucosidase alfa-ngpt
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

avalglucosidase alfa 100 mg/10mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0426
Product ID 58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761194
Listing Expiration 2026-12-31
Marketing Start 2021-08-06

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal glycogen-specific enzyme [epc]
Chemical Structure
alpha-glucosidases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680426
Hyphenated Format 58468-0426

Supplemental Identifiers

RxCUI
2565818 2565823
UNII
EO144CP0X9
NUI
M0000794 N0000175821

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 nexviazyme (source: ndc)
Generic Name avalglucosidase alfa-ngpt (source: ndc)
Application Number BLA761194 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

58468-0426-1 1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

avalglucosidase alfa (100 mg/10mL)

Linked Drug Pages (1)

Nexviazyme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "583725c8-1d65-4479-b93b-b945bfe8a39b", "openfda": {"nui": ["M0000794", "N0000175821"], "unii": ["EO144CP0X9"], "rxcui": ["2565818", "2565823"], "spl_set_id": ["80eb3c9c-01d3-44fe-90ef-81df101b954d"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "58468-0426-1", "marketing_start_date": "20210806"}], "brand_name": "Nexviazyme", "product_id": "58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0426", "generic_name": "avalglucosidase alfa-ngpt", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexviazyme", "active_ingredients": [{"name": "AVALGLUCOSIDASE ALFA", "strength": "100 mg/10mL"}], "application_number": "BLA761194", "marketing_category": "BLA", "marketing_start_date": "20210806", "listing_expiration_date": "20261231"}