elaprase

Generic: idursulfase

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name elaprase
Generic Name idursulfase
Labeler takeda pharmaceuticals america, inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

idursulfase 6 mg/3mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-700
Product ID 54092-700_25f45811-e646-4342-9954-d8220cadf886
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125151
Listing Expiration 2026-12-31
Marketing Start 2006-07-24

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 54092700
Hyphenated Format 54092-700

Supplemental Identifiers

RxCUI
644104 647118
UNII
5W8JGG2651
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 elaprase (source: ndc)
Generic Name idursulfase (source: ndc)
Application Number BLA125151 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/3mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

54092-700-01 1 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS

Ingredients (1)

idursulfase (6 mg/3mL)

Linked Drug Pages (1)

ELAPRASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "25f45811-e646-4342-9954-d8220cadf886", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["5W8JGG2651"], "rxcui": ["644104", "647118"], "spl_set_id": ["60cba843-5aab-4dd7-96dc-66648d413be3"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BOX (54092-700-01)  / 3 mL in 1 VIAL, GLASS", "package_ndc": "54092-700-01", "marketing_start_date": "20060724"}], "brand_name": "ELAPRASE", "product_id": "54092-700_25f45811-e646-4342-9954-d8220cadf886", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "54092-700", "generic_name": "idursulfase", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELAPRASE", "active_ingredients": [{"name": "IDURSULFASE", "strength": "6 mg/3mL"}], "application_number": "BLA125151", "marketing_category": "BLA", "marketing_start_date": "20060724", "listing_expiration_date": "20261231"}