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  5. NDC Package Code: 70121-1631-1 Tepadina

NDC Package 70121-1631-1 Tepadina

Thiotepa Injection, Powder, For Solution Intracavitary; Intravenous; Intravesical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70121-1631-1
Package Description:
1 VIAL, GLASS in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Product Code:
70121-1631
Proprietary Name:
Tepadina
Non-Proprietary Name:
Thiotepa
Substance Name:
Thiotepa
Usage Information:
Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer. Thiotepa is also used with other medications to prevent rejection of a stem cell transplant.
11-Digit NDC Billing Format:
70121163101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1660004 - thiotepa 100 MG Injection
  • RxCUI: 1660004 - TSPA 100 MG Injection
  • RxCUI: 1660009 - thiotepa 15 MG Injection
  • RxCUI: 1660009 - TSPA 15 MG Injection
  • RxCUI: 1919209 - TEPADINA 100 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intracavitary - Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that which is formed as the result of a wound.
  • Intravenous - Administration within or into a vein or veins.
  • Intravesical - Administration within the bladder.
    • Active Ingredient(s):
  • THIOTEPA 100 mg/1
    • Pharmacologic Class(es):
  • Alkylating Activity - [MoA] (Mechanism of Action)
  • Alkylating Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA208264
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-15-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70121-1631-1?

    The NDC Packaged Code 70121-1631-1 is assigned to a package of 1 vial, glass in 1 box / 1 injection, powder, for solution in 1 vial, glass of Tepadina, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is injection, powder, for solution and is administered via intracavitary; intravenous; intravesical form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 70121-1631 included in the NDC Directory?

    Yes, Tepadina with product code 70121-1631 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on August 15, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70121-1631-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 70121-1631-1?

    The 11-digit format is 70121163101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-170121-1631-15-4-270121-1631-01