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  4. NDC Product Code: 60215-111 Choline C 11

NDC 60215-111 Choline C 11

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 60215-111?
  4. Choline C 11 Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
60215-111
Proprietary Name:
Choline C 11
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
The University Of Texas Md Anderson Cancer Center
Labeler Code:
60215
Product Label ID:
61f00cb4-ea53-4ba6-a890-78586095d2f6
Start Marketing Date: [9]
10-29-2015
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

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Product Details

What is NDC 60215-111?

The NDC code 60215-111 is assigned by the FDA to the product Choline C 11 which is product labeled by The University Of Texas Md Anderson Cancer Center. The product's dosage form is . The product is distributed in a single package with assigned NDC code 60215-111-10 10 ml in 1 vial, glass . 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 Choline C 11?

Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspectedprostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magneticresonance imaging (MRI). In these patients, 11C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based uponelevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images wereproduced with PET/CT coregistration.Limitation of Use:11C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.

Which are Choline C 11 UNII Codes?

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

Which are Choline C 11 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

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

[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".