Suprep Bowel Prep Solution, Concentrate
NDC Package 52268-112-01
Package Information
Suprep Bowel Prep (sodium sulfate, potassium sulfate, magnesium sulfate) solution is sUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults. This formulation utilizes a solution, concentrate delivery system. Marketed by Braintree Laboratories, Inc., this product is identified by NDC 52268-112 and is authorized under FDA application NDA022372.
Identification & Billing
- RxCUI: 1001689 - {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack
- RxCUI: 1001689 - 2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack
- RxCUI: 1001690 - {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack [Suprep Bowel Prep Kit]
- RxCUI: 1001690 - SUPREP BOWEL PREP KIT
- RxCUI: 1001690 - {2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) } Pack [Suprep Bowel Prep Kit]
Clinical Specifications
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
Regulatory & Marketing
Hierarchy Structure
- 52268 - Braintree Laboratories, Inc.
- 52268-112 - Suprep Bowel Prep
- 52268-112-01 - 2 BOTTLE, PLASTIC in 1 CARTON / 133.1 mL in 1 BOTTLE, PLASTIC
- 52268-112 - Suprep Bowel Prep
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 52268-112-01 identifies a specific commercial package of 2 bottle, plastic in 1 carton / 133.1 ml in 1 bottle, plastic of Suprep Bowel Prep, a human prescription drug labeled by Braintree Laboratories, Inc.. This solution, concentrate is formulated for oral use and contains magnesium sulfate, unspecified form; potassium sulfate; sodium sulfate 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 August 05, 2010. The current certification is valid through December 31, 2027.
How is this Braintree Laboratories, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 52268011201. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.