Home NDC 0069-0106-01 ELELYSO
Product NDC 0069-0106
Requested package NDC 0069-0106-01
11-digit product format 000690106
Labeler code 0069
Product ID 0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Taliglucerase alfa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA022458
Marketing category BLA
Marketing start 2012-05-01
Substance TALIGLUCERASE ALFA
Active strength 200 U/5mL
Pharmacologic classes Glucosylceramidase [CS], Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ELELYSO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TALIGLUCERASE ALFA 200 U/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0R4NLX88O4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1292879 Internal RxNorm lookup 1292881 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0106-01 ELELYSO 5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 5 31 0069-0106-01 ELELYSO 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0106 ELELYSO (TALIGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 30 Current NDC, Legacy NDC, 2 package rows 20250129_fa3cbd5d-677c-4b19-9032-d9182cb69a83.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022458 Elelyso taliglucerase alfa 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0069-0106-01 00069010601 1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASS 2012-05-01 0000-00-00 No No Current