Home NDC 69794-001 MEPSEVII
Product NDC 69794-001
11-digit product format 697940001
Labeler code 69794
Product ID 69794-001_6e20f052-5a5f-41cd-ab55-97b8a9bf6562
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vestronidase alfa
Dosage form INJECTION
Route INTRAVENOUS
Labeler Ultragenyx Pharmaceutical Inc.
Application BLA761047
Marketing category BLA
Marketing start 2017-11-15
Substance VESTRONIDASE ALFA
Active strength 2 mg/mL
Pharmacologic classes Lysosomal beta Glucuronidase [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base MEPSEVII
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VESTRONIDASE ALFA 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7XZ4062R17 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1989823 Internal RxNorm lookup 1989828 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69794-001-01 MEPSEVII 5 mL in 1 VIAL, SINGLE-USE INJECTION 5 17 69794-001-01 MEPSEVII 1 in 1 CARTON INJECTION 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69794-001 MEPSEVII (VESTRONIDASE ALFA) INJECTION [ULTRAGENYX PHARMACEUTICAL INC.] 16 Current NDC, Legacy NDC, 2 package rows 20250117_925d4e21-fd98-474d-a34d-a0b3558ed750.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MEPSEVII VESTRONIDASE ALFA Ultragenyx Pharmaceutical Inc. 925d4e21-fd98-474d-a34d-a0b3558ed750 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761047 ndc (product): 69794-001
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761047 Mepsevii vestronidase alfa-vjbk 351(a) Rx 2026-08-01
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 69794-001-01 69794000101 1 VIAL, SINGLE-USE in 1 CARTON (69794-001-01) / 5 mL in 1 VIAL, SINGLE-USE 2017-11-15 0000-00-00 No No Current