Suflave Kit
NDC Package 52268-550-01

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

Package Information

Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) kits is sUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. This formulation utilizes a kit delivery system. Marketed by Braintree Laboratories, Inc., this product is identified by NDC 52268-550 and is authorized under FDA application NDA215344.

Identification & Billing

NDC Package Code
52268-550-01
Package Description
1 KIT in 1 KIT
Product Code
52268-550
11-Digit Billing Format
52268055001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2641142 - polyethylene glycol 3350 178.7 GM / potassium chloride 1.12 GM / magnesium sulfate 0.9 GM / sodium chloride 0.5 GM / sodium sulfate 7.3 GM Powder for Oral Solution
  • RxCUI: 2641142 - magnesium sulfate 900 MG / polyethylene glycol 3350 179000 MG / potassium chloride 1120 MG / sodium chloride 500 MG / sodium sulfate 7300 MG Powder for Oral Solution
  • RxCUI: 2641142 - magnesium sulfate 900 MG / polyethylene glycol 3350 179000 MG / K+ chloride 1120 MG / NaCl 500 MG / sodium sulfate 7300 MG Powder for Oral Solution
  • RxCUI: 2641142 - magnesium sulfate 900 MG / polyethylene glycol 3350 179000 MG / Pot chloride 1120 MG / NaCl 500 MG / sodium sulfate 7300 MG Powder for Oral Solution
  • RxCUI: 2641143 - {2 (magnesium sulfate 900 MG / polyethylene glycol 3350 179000 MG / potassium chloride 1120 MG / sodium chloride 500 MG / sodium sulfate 7300 MG Powder for Oral Solution) } Pack

Clinical Specifications

Proprietary Name
Suflave
Non-Proprietary Name
Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution
Dosage Form
Kit - A packaged collection of related material.
Usage Information
SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

Regulatory & Marketing

Labeler Name
Braintree Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215344
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-15-2023
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 52268-550-01 identifies a specific commercial package of 1 kit in 1 kit of Suflave, a human prescription drug labeled by Braintree Laboratories, Inc.. This kit is formulated for use and contains 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 Braintree Laboratories, Inc. on June 15, 2023. The current certification is valid through December 31, 2026.

How is this Braintree Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52268055001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
52268-550-01
11-Digit CMS (5-4-2)
52268-0550-01

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