Hycamtin Capsule
NDC Package 66758-101-11

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

Hycamtin (topotecan) capsules is a medication used to treat small cell lung cancer. This formulation utilizes a capsule delivery system. Marketed by Sandoz Inc, this product is identified by NDC 66758-101 and is authorized under FDA application NDA020981.

Identification & Billing

NDC Package Code
66758-101-11
Package Description
10 CAPSULE in 1 BOTTLE
Product Code
66758-101
11-Digit Billing Format
66758010111
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hycamtin
Non-Proprietary Name
Topotecan
Substance Name
Topotecan Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOPOTECAN HYDROCHLORIDE .25 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat small cell lung cancer. It works by killing cancer cells or slowing their growth.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020981
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-07-2017
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.

J8705
Source: ASP
Topotecan oral
HCPCS Dosage 0.25 MG
Units / Pkg 10

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 66758-101-11 identifies a specific commercial package of 10 capsule in 1 bottle of Hycamtin, a human prescription drug labeled by Sandoz Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This capsule is formulated for oral 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 Sandoz Inc on July 07, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat small cell lung cancer. It works by killing cancer cells or slowing their growth.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66758010111. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
66758-101-11
11-Digit CMS (5-4-2)
66758-0101-11

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