Soltamox Liquid
NDC Package 51862-682-01

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

Package Information

Soltamox (tamoxifen citrate) liquids is tamoxifen is used to treat breast cancer. This formulation utilizes a liquid delivery system. Marketed by Mayne Pharma, this product is identified by NDC 51862-682 and is authorized under FDA application NDA021807.

Identification & Billing

NDC Package Code
51862-682-01
Package Description
1 CONTAINER in 1 CARTON / 150 mL in 1 CONTAINER
Product Code
51862-682
11-Digit Billing Format
51862068201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Soltamox
Non-Proprietary Name
Tamoxifen Citrate
Substance Name
Tamoxifen Citrate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TAMOXIFEN CITRATE 20 mg/10mL
Pharmacologic Class
Usage Information
Tamoxifen is used to treat breast cancer. It is also used to reduce the chances of breast cancer in high-risk patients. This medication can block the growth of breast cancer. It works by interfering with the effects of estrogen in the breast tissue.

Regulatory & Marketing

Labeler Name
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA021807
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51862-682). Click a package code to view its specific billing and regulatory data.

51862-682-00
1 CONTAINER in 1 CARTON / 150 mL in 1 CONTAINER

* 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 51862-682-01 identifies a specific commercial package of 1 container in 1 carton / 150 ml in 1 container of Soltamox, a human prescription drug labeled by Mayne Pharma. This liquid is formulated for oral use and contains tamoxifen citrate 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 Mayne Pharma on June 18, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tamoxifen is used to treat breast cancer. It is also used to reduce the chances of breast cancer in high-risk patients. This medication can block the growth of breast cancer. It works by interfering with the effects of estrogen in the breast tissue.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862068201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51862-682-01
11-Digit CMS (5-4-2)
51862-0682-01

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