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  4. NDC Product Code: 65857-425 Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept)

NDC 65857-425 Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept)

Tilmanocept Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 65857-425?
  4. Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
65857-425
Proprietary Name:
Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept)
Non-Proprietary Name: [1]
Tilmanocept
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Cardinal Health 414, Llc
Labeler Code:
65857
Product Label ID:
72f31b09-4d7b-475c-b37a-9daf2ad80240
FDA Application Number: [6]
NDA202207
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
09-20-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 65857-425?

The NDC code 65857-425 is assigned by the FDA to the product Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) which is a human prescription drug product labeled by Cardinal Health 414, Llc. The generic name of Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) is tilmanocept. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 65857-425-05 1 kit in 1 carton / 1 kit in 1 kit * 1 injection, powder, lyophilized, for solution in 1 vial (65857-400-01). 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 Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept)?

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:•Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.•Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Which are Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) UNII Codes?

The UNII codes for the active ingredients in this product are:

  • TECHNETIUM TC-99M TILMANOCEPT (UNII: 8IHI69PQTC)
  • TECHNETIUM TC-99M TILMANOCEPT (UNII: 8IHI69PQTC) (Active Moiety)

Which are Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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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.

[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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[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".