Isolyte P In Dextrose Injection, Solution
NDC Package 0264-7730-10
Package Information
Isolyte P In Dextrose (dextrose, sodium acetate, potassium chloride, magnesium chloride, and potassium phosphate, dibasic) injection is this solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent. This formulation utilizes a injection, solution delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-7730 and is authorized under FDA application NDA019873.
Identification & Billing
- RxCUI: 800808 - dibasic potassium phosphate 0.26 MG/ML / glucose 50 MG/ML / magnesium chloride 0.00373 MEQ/ML / potassium chloride 0.00174 MEQ/ML / sodium acetate 0.039 MEQ/ML Injectable Solution
- RxCUI: 800808 - Dibasic K+ phosphate 0.26 MG/ML / Glucose 50 MG/ML / Magnesium Chloride 0.00373 MEQ/ML / K+ Chloride 0.00174 MEQ/ML / Sodium Acetate 0.039 MEQ/ML Injectable Solution
- RxCUI: 800808 - Dibasic Pot phosphate 0.26 MG/ML / Glucose 50 MG/ML / Magnesium Chloride 0.00373 MEQ/ML / Pot Chloride 0.00174 MEQ/ML / Sodium Acetate 0.039 MEQ/ML Injectable Solution
- RxCUI: 800812 - Isolyte P in 5 % Dextrose Injectable Solution
- RxCUI: 800812 - dibasic potassium phosphate 0.26 MG/ML / glucose 50 MG/ML / magnesium chloride 0.00373 MEQ/ML / potassium chloride 0.00174 MEQ/ML / sodium acetate 0.039 MEQ/ML Injectable Solution [Isolyte P]
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
- 0264 - B. Braun Medical Inc.
- 0264-7730 - Isolyte P In Dextrose
- 0264-7730-10 - 24 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER
- 0264-7730 - Isolyte P In Dextrose
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 0264-7730-10 identifies a specific commercial package of 24 container in 1 case / 500 ml in 1 container of Isolyte P In Dextrose, a human prescription drug labeled by B. Braun Medical Inc.. This injection, solution is formulated for intravenous use and contains dextrose monohydrate; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate 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 B. Braun Medical Inc. on June 10, 1993. The current certification is valid through December 31, 2026.
How is this B. Braun Medical Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264773010. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.