Mineral Oil
NDC Package 49348-804-38

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Mineral Oil is used to treat constipation. Marketed by Mckesson (sunmark), this product is identified by NDC 49348-804 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
49348-804-38
Package Description
473 mg in 1 BOTTLE, PLASTIC
Product Code
49348-804
11-Digit Billing Format
49348080438
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Mineral Oil
Dosage Form
-
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
Mckesson (sunmark)
FDA Application #
part334
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-29-2009
End Marketing Date
11-25-2017
Listing Expiration
11-25-2017
Exclude Flag
D
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 49348-804-38 identifies a specific commercial package of 473 mg in 1 bottle, plastic of Mineral Oil, labeled by Mckesson (sunmark). This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mckesson (sunmark) on September 29, 2009. The current certification is valid through November 25, 2017.

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 Mckesson (sunmark) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348080438. 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)
49348-804-38
11-Digit CMS (5-4-2)
49348-0804-38

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