Sorbitol Irrigant
NDC Package 0338-0295-47

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

Package Information

Sorbitol irrigants is a medication used as a laxative to treat occasional episodes of constipation. This formulation utilizes a irrigant delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0295 and is authorized under FDA application NDA017863.

Identification & Billing

NDC Package Code
0338-0295-47
Package Description
3000 mL in 1 BAG
Product Code
0338-0295
11-Digit Billing Format
00338029547
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
3000 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sorbitol
Non-Proprietary Name
Sorbitol
Substance Name
Sorbitol
Dosage Form
Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.
Administration Route
Irrigation - Administration to bathe or flush open wounds or body cavities.
Active Ingredient(s)
SORBITOL 30 g/1000mL
Usage Information
This medication is used as a laxative to treat occasional episodes of constipation. Depending on the brand, this product may be taken by mouth and/or given rectally. Some products may only be given rectally. Be sure to check the label on your product for how to take your specific product.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA017863
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-30-1980
Listing Expiration
12-31-2027
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 0338-0295-47 identifies a specific commercial package of 3000 ml in 1 bag of Sorbitol, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 3000 billable units per package. This irrigant is formulated for irrigation use and contains sorbitol 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 Baxter Healthcare Corporation on May 30, 1980. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used as a laxative to treat occasional episodes of constipation. Depending on the brand, this product may be taken by mouth and/or given rectally. Some products may only be given rectally. Be sure to check the label on your product for how to take your specific product.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338029547. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 3000 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 (4-4-2)
0338-0295-47
11-Digit CMS (5-4-2)
00338-0295-47

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