Saline Enema
NDC Package 67777-402-02

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

Package Information

Saline Enema (sodium phosphate monobasic, sodium phosphate dibasic) enemas is do not use more unless directed by a doctorSee WarningsAdults and children 12 years and older - 1 bottleChildren 2 to under 12 years - 1/2 bottleChildren under 2 years - Do not use. This formulation utilizes a enema delivery system. Marketed by Dynarex Corporation, this product is identified by NDC 67777-402 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
67777-402-02
Package Description
48 BOX in 1 CASE / 1 BOTTLE in 1 BOX (67777-402-01) / 133 mL in 1 BOTTLE
Product Code
67777-402
11-Digit Billing Format
67777040202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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 Enema
Non-Proprietary Name
Sodium Phosphate Monobasic, Sodium Phosphate Dibasic
Substance Name
Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic
Dosage Form
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Usage Information
Do not use more unless directed by a doctorSee WarningsAdults and children 12 years and older - 1 bottleChildren 2 to under 12 years - 1/2 bottleChildren under 2 years - Do not use. Consult a physician.

Regulatory & Marketing

Labeler Name
Dynarex Corporation
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-29-2012
Listing Expiration
12-31-2026
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 67777-402-02 identifies a specific commercial package of 48 box in 1 case / 1 bottle in 1 box (67777-402-01) / 133 ml in 1 bottle of Saline Enema, a human over the counter drug labeled by Dynarex Corporation. This enema is formulated for rectal use and contains sodium phosphate, dibasic; sodium phosphate, monobasic 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 Dynarex Corporation on August 29, 2012. The current certification is valid through December 31, 2026.

How is this Dynarex Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67777040202. 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)
67777-402-02
11-Digit CMS (5-4-2)
67777-0402-02

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