Tepylute
NDC 81927-105
View NDC Profile UNII Mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Tepylute is a NDA-approved product labeled by Shorla Oncology Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 81927-105 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
81927-105
Proprietary Name:
Tepylute
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
81927
Product Label ID:
FDA Application Number: [6]
NDA216984
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-31-2025
End Marketing Date: [10]
09-30-2026
Listing Expiration Date: [11]
09-30-2026
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 81927-105?
The NDC code 81927-105 is assigned by the FDA to the product Tepylute. This pharmaceutical product is labeled by Shorla Oncology Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 81927-105-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
TEPYLUTE is indicated for treatment of adenocarcinoma of the breast or ovary.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- THIOTEPA (UNII: 905Z5W3GKH)
- THIOTEPA (UNII: 905Z5W3GKH) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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Patient Education
Thiotepa Injection
Thiotepa injection is used to treat certain types of ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), breast, and bladder cancer. It is also used to treat malignant effusions (a condition when fluid collects in the lungs or around the heart) that are caused by cancerous tumors. Thiotepa is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
