FDA.reportPublic FDA data

RASONQUE

Product NDC
85219-104
Requested package NDC
85219-104-01
11-digit product format
852190104
Labeler code
85219
Product ID
85219-104_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
150 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220910-001RASONQUEDARAXONRASIB100MGTABLET / ORALRLD2026-08-26
N220910-002RASONQUEDARAXONRASIB150MGTABLET / ORALRLD, RS2026-08-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220910-001RASONQUE100MGTABLET / ORALRLD2026-08-2684e616aacf4f…
2026-09-14 22:38:342026-08N220910-002RASONQUE150MGTABLET / ORALRLD, RS2026-08-2684e616aacf4f…

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
IngredientStrength
DARAXONRASIB150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6T47Y2UAPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2750160Internal RxNorm lookup
2750166Internal RxNorm lookup
2750168Internal RxNorm lookup
2750170Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13a65923-d072-4dac-8620-8eabbf8c3641Available on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RASONQUEDARAXONRASIBRevolution Medicines, Inc.13a65923-d072-4dac-8620-8eabbf8c36412026-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 220910
application number: NDA220910
ndc (package): 85219-104-01
ndc (product): 85219-104
ndc11 (package): 85219010401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85219-104-01852190104011 BOTTLE in 1 CARTON (85219-104-01) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-08-26NoNoCurrent