Topotecan Hydrochloride Injection, Powder, Lyophilized, For Solution
NDC Package 16729-151-31

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

Topotecan Hydrochloride injection is topotecan Hydrochloride for Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Accord Healthcare, Inc., this product is identified by NDC 16729-151 and is authorized under FDA application ANDA202351.

Identification & Billing

NDC Package Code
16729-151-31
Package Description
1 VIAL in 1 PACKAGE / 4 mL in 1 VIAL
Product Code
16729-151
11-Digit Billing Format
16729015131
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
Topotecan Hydrochloride
Non-Proprietary Name
Topotecan Hydrochloride
Substance Name
Topotecan Hydrochloride
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TOPOTECAN HYDROCHLORIDE 4 mg/4mL
Pharmacologic Class
Usage Information
Topotecan Hydrochloride for Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions ( 6.2)] .

Regulatory & Marketing

Labeler Name
Accord Healthcare, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202351
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2013
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.

J9351
Source: ASP
Topotecan injection
HCPCS Dosage 0.1 MG
Units / Pkg 40

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 16729-151-31 identifies a specific commercial package of 1 vial in 1 package / 4 ml in 1 vial of Topotecan Hydrochloride, a human prescription drug labeled by Accord Healthcare, Inc.. 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 intravenous use and contains topotecan hydrochloride 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 Accord Healthcare, Inc. on July 23, 2013. The current certification is valid through December 31, 2026.

How is this Accord Healthcare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729015131. 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)
16729-151-31
11-Digit CMS (5-4-2)
16729-0151-31

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