Miralax Powder, For Solution
NDC Package 11523-4357-2

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

Miralax (polyethylene glycol 3350) powders is a medication used to treat occasional constipation. This formulation utilizes a powder, for solution delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 11523-4357 and is authorized under FDA application NDA022015.

Identification & Billing

NDC Package Code
11523-4357-2
Package Description
2 CARTON in 1 CARTON / 20 PACKET in 1 CARTON / 17 g in 1 PACKET
Product Code
11523-4357
11-Digit Billing Format
11523435702
RxNorm Crosswalk
  • RxCUI: 876193 - polyethylene glycol 3350 17 GM Powder for Oral Solution
  • RxCUI: 876193 - polyethylene glycol 3350 17000 MG Powder for Oral Solution
  • RxCUI: 876195 - MiraLAX 17 GM Powder for Oral Solution
  • RxCUI: 876195 - polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]
  • RxCUI: 876195 - Miralax 17 GM Powder for Oral Solution

Clinical Specifications

Proprietary Name
Miralax
Non-Proprietary Name
Polyethylene Glycol 3350
Substance Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POLYETHYLENE GLYCOL 3350 17 g/17g
Pharmacologic Class
Usage Information
This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
NDA022015
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2007
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11523-4357). Click a package code to view its specific billing and regulatory data.

11523-4357-1
2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION / 765 g in 1 BOTTLE, PLASTIC
11523-4357-3
2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION / 578 g in 1 BOTTLE, PLASTIC
11523-4357-5
24 PACKET in 1 CARTON / 17 g in 1 PACKET

* 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 11523-4357-2 identifies a specific commercial package of 2 carton in 1 carton / 20 packet in 1 carton / 17 g in 1 packet of Miralax, a human over the counter drug labeled by Bayer Healthcare Llc.. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350 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 Bayer Healthcare Llc. on February 01, 2007. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

How is this Bayer Healthcare Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11523435702. 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)
11523-4357-2
11-Digit CMS (5-4-2)
11523-4357-02

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