elelyso

Generic: taliglucerase alfa

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name elelyso
Generic Name taliglucerase alfa
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

taliglucerase alfa 200 U/5mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0106
Product ID 0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022458
Listing Expiration 2026-12-31
Marketing Start 2012-05-01

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal glucocerebroside-specific enzyme [epc]
Chemical Structure
glucosylceramidase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690106
Hyphenated Format 0069-0106

Supplemental Identifiers

RxCUI
1292879 1292881
UNII
0R4NLX88O4
NUI
N0000175820 M0009360

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 elelyso (source: ndc)
Generic Name taliglucerase alfa (source: ndc)
Application Number BLA022458 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 U/5mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0069-0106-01 1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASS

Ingredients (1)

taliglucerase alfa (200 U/5mL)

Linked Drug Pages (1)

ELELYSO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d7eb51c8-fe18-46f2-8d97-eaa343ec8821", "openfda": {"nui": ["N0000175820", "M0009360"], "unii": ["0R4NLX88O4"], "rxcui": ["1292879", "1292881"], "spl_set_id": ["fa3cbd5d-677c-4b19-9032-d9182cb69a83"], "pharm_class_cs": ["Glucosylceramidase [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0069-0106-01)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "0069-0106-01", "marketing_start_date": "20120501"}], "brand_name": "ELELYSO", "product_id": "0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glucosylceramidase [CS]", "Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "product_ndc": "0069-0106", "generic_name": "Taliglucerase alfa", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELELYSO", "active_ingredients": [{"name": "TALIGLUCERASE ALFA", "strength": "200 U/5mL"}], "application_number": "BLA022458", "marketing_category": "BLA", "marketing_start_date": "20120501", "listing_expiration_date": "20261231"}