Home NDC 85219-101 RASONQUE
Product NDC 85219-101
11-digit product format 852190101
Labeler code 85219
Product ID 85219-101_107d4cd9-2e5e-419d-9449-7ef84f5fbcc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daraxonrasib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Revolution Medicines, Inc.
Application NDA220910
Marketing category NDA
Marketing start 2026-08-26
Substance DARAXONRASIB
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220910-001 RASONQUE DARAXONRASIB 100MG TABLET / ORAL RLD 2026-08-26 N220910-002 RASONQUE DARAXONRASIB 150MG TABLET / ORAL RLD, RS 2026-08-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N220910-001 RASONQUE 100MG TABLET / ORAL RLD 2026-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220910-002 RASONQUE 150MG TABLET / ORAL RLD, RS 2026-08-26 84e616aacf4f…
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 RASONQUE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARAXONRASIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B6T47Y2UAP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2750160 Internal RxNorm lookup 2750166 Internal RxNorm lookup 2750168 Internal RxNorm lookup 2750170 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 Exclude flag Status 85219-101-01 85219010101 1 BOTTLE in 1 CARTON (85219-101-01) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-08-26 No No Current