vimizim

Generic: elosulfase alfa

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vimizim
Generic Name elosulfase alfa
Labeler biomarin pharmaceutical inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

elosulfase alfa 5 mg/5mL

Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-100
Product ID 68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125460
Listing Expiration 2026-12-31
Marketing Start 2014-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135100
Hyphenated Format 68135-100

Supplemental Identifiers

RxCUI
1490047 1490052
UNII
ODJ69JZG85
NUI
M0000794 N0000175823

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 vimizim (source: ndc)
Generic Name elosulfase alfa (source: ndc)
Application Number BLA125460 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68135-100-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68135-100-01 1 VIAL in 1 CARTON (68135-100-01) / 5 mL in 1 VIAL

Ingredients (1)

elosulfase alfa (5 mg/5mL)

Linked Drug Pages (1)

VIMIZIM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d3f50b07-ab7c-4922-83b5-6441be0c3c11", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["ODJ69JZG85"], "rxcui": ["1490047", "1490052"], "spl_set_id": ["0caa2565-12b2-0ad0-1f9a-273e81c3d4cc"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68135-100-01)  / 5 mL in 1 VIAL", "package_ndc": "68135-100-01", "marketing_start_date": "20140214"}], "brand_name": "VIMIZIM", "product_id": "68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "68135-100", "generic_name": "elosulfase alfa", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIMIZIM", "active_ingredients": [{"name": "ELOSULFASE ALFA", "strength": "5 mg/5mL"}], "application_number": "BLA125460", "marketing_category": "BLA", "marketing_start_date": "20140214", "listing_expiration_date": "20261231"}