Saline Laxative
NDC Package 49348-005-35

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Saline Laxative is do not use more unless directed by a doctor. Marketed by Mckesson, this product is identified by NDC 49348-005 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
49348-005-35
Package Description
2 BOTTLE in 1 BOX / 133 mL in 1 BOTTLE
Product Code
49348-005
11-Digit Billing Format
49348000535
RxNorm Crosswalk
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema

Clinical Specifications

Proprietary Name
Saline Laxative
Dosage Form
-
Usage Information
Do not use more unless directed by a doctor. See Warnings.adults & children 12 years and overone bottle once dailychildren 2 to under12 years1/2 bottle once dailychildren under2 yearsdo not useCAUTION:Remove green protective shield before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.Positioning:Left-side position: lie on left side with knee bent and arms at rest.Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.Administering enema:•with steady pressure, gently insert enema with tip pointing toward navel.•squeeze bottle until recommended dose is expelled (it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing). •remove tip from rectum•stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.•maintain position until urge to evacuate is strong (usually 1 to 5 minutes)•if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Regulatory & Marketing

Labeler Name
Mckesson
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
08-31-2012
Listing Expiration
12-31-2017
Exclude Flag
I
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 (49348-005). Click a package code to view its specific billing and regulatory data.

49348-005-11
1 BOTTLE in 1 BOX / 133 mL in 1 BOTTLE

* 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 49348-005-35 identifies a specific commercial package of 2 bottle in 1 box / 133 ml in 1 bottle of Saline Laxative, labeled by Mckesson. 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 on August 31, 2012. The current certification is valid through December 31, 2017.

How is this Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348000535. 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)
49348-005-35
11-Digit CMS (5-4-2)
49348-0005-35

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