Thiotepa Injection, Powder, Lyophilized, For Solution
NDC Package 72205-045-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Thiotepa injection is thiotepa is used to treat cancer. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-045 and is authorized under FDA application ANDA213049.

Identification & Billing

NDC Package Code
72205-045-01
Package Description
1 VIAL, GLASS in 1 BOX / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Product Code
72205-045
11-Digit Billing Format
72205004501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thiotepa
Non-Proprietary Name
Thiotepa
Substance Name
Thiotepa
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
  • 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 15 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9342
Source: ASP
Inj thiotepa nos 1 mg
HCPCS Dosage 1 MG
Units / Pkg 15

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72205-045-01 identifies a specific commercial package of 1 vial, glass in 1 box / 1 injection, powder, lyophilized, for solution in 1 vial, glass of Thiotepa, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intracavitary; intravenous; intravesical use and contains thiotepa as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novadoz Pharmaceuticals Llc on February 01, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205004501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72205-045-01
11-Digit CMS (5-4-2)
72205-0045-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.