Prosol Injection, Solution
NDC Package 0338-0499-06

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

Package Information

Prosol (valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine) injection is 20% PROSOL - sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0499 and is authorized under FDA application NDA020849.

Identification & Billing

NDC Package Code
0338-0499-06
Package Description
2000 mL in 1 BAG
Product Code
0338-0499
11-Digit Billing Format
00338049906
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
2000 ML
RxNorm Crosswalk
  • RxCUI: 801133 - alanine 27.6 MG/ML / arginine 19.6 MG/ML / aspartate 6 MG/ML / glutamate 10.2 MG/ML / glycine 20.6 MG/ML / histidine 11.8 MG/ML / isoleucine 10.8 MG/ML / leucine 10.8 MG/ML / lysine 13.5 MG/ML / methionine 7.6 MG/ML / phenylalanine 10 MG/ML / proline 13.4 MG/ML / serine 10.2 MG/ML / threonine 9.8 MG/ML / tryptophan 3.2 MG/ML / tyrosine 0.5 MG/ML / valine 14.4 MG/ML Injectable Solution
  • RxCUI: 801136 - ProSol 20 % Injectable Solution
  • RxCUI: 801136 - alanine 27.6 MG/ML / arginine 19.6 MG/ML / aspartate 6 MG/ML / glutamate 10.2 MG/ML / glycine 20.6 MG/ML / histidine 11.8 MG/ML / isoleucine 10.8 MG/ML / leucine 10.8 MG/ML / lysine 13.5 MG/ML / methionine 7.6 MG/ML / phenylalanine 10 MG/ML / proline 13.4 MG/ML / serine 10.2 MG/ML / threonine 9.8 MG/ML / tryptophan 3.2 MG/ML / tyrosine 0.5 MG/ML / valine 14.4 MG/ML Injectable Solution [Prosol]
  • RxCUI: 801136 - ProSol 20 % Amino Acid Injectable Solution

Clinical Specifications

Proprietary Name
Prosol
Non-Proprietary Name
Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
Substance Name
Alanine; Arginine; Aspartic Acid; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
20% PROSOL - sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. 20% PROSOL - sulfite-free (Amino Acid) Injection can be used to reduce fluid intake in patients who require both fluid restriction and total parenteral nutrition (TPN). 20% PROSOL - sulfite-free (Amino Acid) Injection is intended to be dosed on the basis of grams of amino acids/kg body weight/day. Therefore, this more concentrated amino acid solution provides the same nutritional value (grams of total amino acids) as in a more dilute form, but with the opportunity to limit fluid intake.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA020849
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-26-1998
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 0338-0499-06 identifies a specific commercial package of 2000 ml in 1 bag of Prosol, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 2000 billable units per package. This injection, solution is formulated for intravenous use and contains alanine; arginine; aspartic acid; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine 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 Baxter Healthcare Corporation on August 26, 1998. The current certification is valid through December 31, 2026.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338049906. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 2000 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 (4-4-2)
0338-0499-06
11-Digit CMS (5-4-2)
00338-0499-06

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