Home NDC 85001-101 JIDEYTRO
Product NDC 85001-101
11-digit product format 850010101
Labeler code 85001
Product ID 85001-101_6c672099-2978-474e-b783-973fe94efcfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zidesamtinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Nuvalent, Inc.
Application NDA220185
Marketing category NDA
Marketing start 2026-07-22
Substance ZIDESAMTINIB
Active strength 25 mg/1
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
Additional Listing Data#
Finished product Yes
Brand name base JIDEYTRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIDESAMTINIB 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MX5KQV5XHC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2748288 Internal RxNorm lookup 2748294 Internal RxNorm lookup 2748296 Internal RxNorm lookup 2748298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 85001-101-01 85001010101 1 BOTTLE in 1 CARTON (85001-101-01) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-07-22 0 Current