NDC 50242-089 Ado-trastuzumab Emtansine

Liquid - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
50242-089
Proprietary Name:
Ado-trastuzumab Emtansine
Non-Proprietary Name: [1]
Ado-trastuzumab Emtansine
Substance Name: [2]
Ado-trastuzumab Emtansine
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Labeler Name: [5]
Genentech, Inc. (ssf)
Labeler Code:
50242
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
02-22-2013
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Product Packages

NDC Code 50242-089-01

Package Description: 120 L in 1 TANK

NDC Code 50242-089-05

Package Description: 200 L in 1 TANK

Product Details

What is NDC 50242-089?

The NDC code 50242-089 is assigned by the FDA to the UNFINISHED product Ado-trastuzumab Emtansine which is drug for further processing product labeled by Genentech, Inc. (ssf). The generic name of Ado-trastuzumab Emtansine is ado-trastuzumab emtansine. The product's dosage form is liquid. The product is distributed in 2 packages with assigned NDC codes 50242-089-01 120 l in 1 tank , 50242-089-05 200 l in 1 tank . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ado-trastuzumab Emtansine?

Trastuzumab emtansine is used to treat certain types of breast cancer. This medication is used to treat tumors that produce more than the normal amount of a certain substance called HER2 protein. This medication is called a monoclonal antibody and microtubule inhibitor conjugate. Trastuzumab emtansine works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells. This monograph is about the following trastuzumab emtansine products: trastuzumab emtansine, ado-trastuzumab emtansine.

What are Ado-trastuzumab Emtansine Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ADO-TRASTUZUMAB EMTANSINE 20 g/L - Immunotoxin that consists of humanized monoclonal anti-HER2 antibody TRASTUZUMAB covalently linked to anti-microtubule agent MAYTANSINOID DM1 for treatment of metastatic breast cancer in patients who previously received trastuzumab and a TAXANES, separately or in combination.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.