Leader Mineral Oil Liquid
NDC Package 70000-0448-1

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

Package Information

Leader Mineral Oil (mineral oil) liquids is mineral oil is used to treat constipation. This formulation utilizes a liquid delivery system. Marketed by Cardinal Health, 110 Dba Leader, this product is identified by NDC 70000-0448 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
70000-0448-1
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
70000-0448
11-Digit Billing Format
70000044801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leader Mineral Oil
Non-Proprietary Name
Mineral Oil
Substance Name
Mineral Oil
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)
MINERAL OIL 1000 mg/mL
Usage Information
Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

Regulatory & Marketing

Labeler Name
Cardinal Health, 110 Dba Leader
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-18-2018
End Marketing Date
02-28-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70000-0448-1 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Leader Mineral Oil, a human over the counter drug labeled by Cardinal Health, 110 Dba Leader. This liquid is formulated for oral use and contains mineral oil 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 Cardinal Health, 110 Dba Leader on December 18, 2018.

What are the primary indications for this medication?

Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

How is this Cardinal Health, 110 Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000044801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-4-1)
70000-0448-1
11-Digit CMS (5-4-2)
70000-0448-01

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