FDA.reportPublic FDA data

DATROWAY

Product NDC
65597-801
11-digit product format
655970801
Labeler code
65597
Product ID
65597-801_b4f34665-c131-4e90-b928-1acc733b7aa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Datopotamab Deruxtecan
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Daiichi Sankyo Inc.
Application
BLA761394
Marketing category
BLA
Marketing start
2025-01-17
Substance
DATOPOTAMAB DERUXTECAN
Active strength
100 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
DATROWAY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DATOPOTAMAB DERUXTECAN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GD2OWY1DTKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2703040Internal RxNorm lookup
2703046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2950227c-6230-4ca4-a135-46e44d9424a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ffca404-0391-4684-9110-aab5f060f7fdProduct name120251110
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65597-801-01DATROWAY5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,517
65597-801-01DATROWAY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-801-01EA - Each65597-801f38a3b50-2b5d-4a35-8231-d238cda6ca1312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-801DATROWAY (DATOPOTAMAB DERUXTECAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DAIICHI SANKYO INC.]7Current NDC, 2 package rows20250523_2950227c-6230-4ca4-a135-46e44d9424a0.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DATROWAYDATOPOTAMAB DERUXTECANDaiichi Sankyo Inc.2950227c-6230-4ca4-a135-46e44d9424a02026-05-27Warnings, Adverse reactionsExact identifier
application number: BLA761394
ndc (product): 65597-801

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761394Datrowaydatopotamab deruxtecan-dlnk351(a)Rx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65597-801-01655970801011 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSE2025-01-17NoNoCurrent