xenpozyme

Generic: olipudase alfa-rpcp

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

Drug Facts

Product Profile

Brand Name xenpozyme
Generic Name olipudase alfa-rpcp
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

olipudase alfa 4 mg/1.1mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0051
Product ID 58468-0051_ce8d4153-ce95-43c4-9672-e1e951ebcdaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761261
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680051
Hyphenated Format 58468-0051

Supplemental Identifiers

RxCUI
2610411 2610416 2634357 2634359
UNII
6D5766Q4OP

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 xenpozyme (source: ndc)
Generic Name olipudase alfa-rpcp (source: ndc)
Application Number BLA761261 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/1.1mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL
source: ndc

Packages (1)

58468-0051-1 1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL

Ingredients (1)

olipudase alfa (4 mg/1.1mL)

Linked Drug Pages (1)

XENPOZYME ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ce8d4153-ce95-43c4-9672-e1e951ebcdaa", "openfda": {"unii": ["6D5766Q4OP"], "rxcui": ["2610411", "2610416", "2634357", "2634359"], "spl_set_id": ["01a910ee-a33e-4be3-ac41-322d64c34311"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (58468-0051-1)  / 1.1 mL in 1 VIAL", "package_ndc": "58468-0051-1", "marketing_start_date": "20220829"}], "brand_name": "XENPOZYME", "product_id": "58468-0051_ce8d4153-ce95-43c4-9672-e1e951ebcdaa", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "58468-0051", "generic_name": "olipudase alfa-rpcp", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XENPOZYME", "active_ingredients": [{"name": "OLIPUDASE ALFA", "strength": "4 mg/1.1mL"}], "application_number": "BLA761261", "marketing_category": "BLA", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}