Home NDC 50242-087 KADCYLA
Product NDC 50242-087
11-digit product format 502420087
Labeler code 50242
Product ID 50242-087_27ab596b-f625-4866-b65a-54508ffce760
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ADO-TRASTUZUMAB EMTANSINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Genentech, Inc.
Application BLA125427
Marketing category BLA
Marketing start 2013-02-22
Substance TRASTUZUMAB EMTANSINE
Active strength 20 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base KADCYLA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRASTUZUMAB EMTANSINE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SE2KH7T06F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658084 Internal RxNorm lookup 1658087 Internal RxNorm lookup 1658089 Internal RxNorm lookup 1658091 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50242-087-01 KADCYLA 8 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 8 35 50242-087-01 KADCYLA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ADO-TRASTUZUMAB EMTANSINE ACTIVE INGREDIENT SE2KH7T06F KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 ADO-TRASTUZUMAB EMTANSINE ACTIVE MOIETY SE2KH7T06F KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-087 KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] 30 Current NDC, Legacy NDC, 2 package rows 20250523_23f3c1f4-0fc8-4804-a9e3-04cf25dd302e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e 2026-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125427 ndc (product): 50242-087
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125427 Kadcyla ado-trastuzumab emtansine 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50242-087-01 50242008701 1 VIAL, SINGLE-USE in 1 CARTON (50242-087-01) / 8 mL in 1 VIAL, SINGLE-USE 2013-02-22 0000-00-00 No No Current