Home NDC 84976-001 AVLAYAH
Product NDC 84976-001
11-digit product format 849760001
Labeler code 84976
Product ID 84976-001_352edb2c-39aa-4955-b456-f5c731b746d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tividenofusp alfa-eknm
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Denali Therapeutics Inc.
Application BLA761485
Marketing category BLA
Marketing start 2026-04-06
Substance TIVIDENOFUSP ALFA
Active strength 150 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base AVLAYAH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIVIDENOFUSP ALFA 150 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QLD7UJN8CF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2740019 Internal RxNorm lookup 2740025 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 84976-001-01 AVLAYAH 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2 84976-001-01 AVLAYAH 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 2
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 AVLAYAH TIVIDENOFUSP ALFA-EKNM Denali Therapeutics Inc. 014d92c1-b643-4680-8ca6-f0b3307da915 2026-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761485 ndc (product): 84976-001
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761485 Avlayah tividenofusp alfa-eknm 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84976-001-01 84976000101 1 VIAL in 1 CARTON (84976-001-01) / 5 mL in 1 VIAL 1 vial 2026-04-06 No No Current