FDA.reportPublic FDA data

TRODELVY

Product NDC
55135-132
11-digit product format
551350132
Labeler code
55135
Product ID
55135-132_18d71575-4896-4cfe-a9e8-a90fbd8bdb8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SACITUZUMAB GOVITECAN
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gilead Sciences, Inc.
Application
BLA761115
Marketing category
BLA
Marketing start
2020-04-22
Substance
SACITUZUMAB GOVITECAN
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRODELVY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACITUZUMAB GOVITECAN180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M9BYU8XDQ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2360534Internal RxNorm lookup
2360539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57a597d2-03f0-472e-b148-016d7169169dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fea35e7f-58c7-4c1d-9124-85f83d3a467eProduct name120200729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55135-132-01TRODELVY1 in 1 BOXPOWDER, FOR SOLUTION118
55135-132-01TRODELVY1 in 1 VIALPOWDER, FOR SOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55135-132-01EA - Each55135-132290cd1c9-c776-4699-ae02-e3325afe58ab12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55135-132TRODELVY (SACITUZUMAB GOVITECAN) POWDER, FOR SOLUTION [GILEAD SCIENCES, INC.]17Current NDC, Legacy NDC, 2 package rows20250406_57a597d2-03f0-472e-b148-016d7169169d.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
TRODELVYSACITUZUMAB GOVITECANGilead Sciences, Inc.57a597d2-03f0-472e-b148-016d7169169d2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761115
ndc (product): 55135-132

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761115Trodelvysacituzumab govitecan-hziy351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360534sacituzumab govitecan-hziy 180 MG InjectionPSN57a597d2-03f0-472e-b148-016d7169169d18
2360539TRODELVY 180 MG InjectionPSN57a597d2-03f0-472e-b148-016d7169169d18
2360539sacituzumab govitecan-hziy 180 MG Injection [Trodelvy]SBD57a597d2-03f0-472e-b148-016d7169169d18
2360534sacituzumab govitecan-hziy 180 MG InjectionSCD57a597d2-03f0-472e-b148-016d7169169d18
2360539Trodelvy 180 MG InjectionSY57a597d2-03f0-472e-b148-016d7169169d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55135-132-01551350132011 VIAL in 1 BOX (55135-132-01) / 1 POWDER, FOR SOLUTION in 1 VIAL1 vial2020-04-230000-00-00NoNoCurrent