NDC Package 0338-0502-03 Clinisol

Lysine,Leucine,Phenylalanine,Valine,Histidine,Isoleucine,Methionine,Threonine,Tryptophan,Alanine,Arginine,Glycine,Proline,Glutamic - View Billable Units, 11-Digit Format, RxNorm

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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0338-0502-03

Package Description:

500 mL in 1 BAG

Product Code:

0338-0502

Proprietary Name:

Clinisol

Non-Proprietary Name:

Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine

Substance Name:

Alanine; Arginine; Aspartic Acid; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine

Usage Information:

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package 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.

11-Digit NDC Billing Format:

00338050203

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

500 ML

NDC to RxNorm Crosswalk:

RxCUI: 800584 - alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution
RxCUI: 800588 - Clinisol 15 % Injectable Solution
RxCUI: 800588 - alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution [Clinisol 15]
RxCUI: 800588 - Clinisol 15 % Amino Acids Injectable Solution

Product Type:

Human Prescription Drug

Labeler Name:

Baxter Healthcare Corporation

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(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA020512

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

08-30-1996

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

0338 - Baxter Healthcare Corporation
- 0338-0502 - Clinisol
  - 0338-0502-03 - 500 mL in 1 BAG

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0338-0502-06	2000 mL in 1 BAG

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0338-0502-03?

The NDC Packaged Code 0338-0502-03 is assigned to a package of 500 ml in 1 bag of Clinisol, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection, solution and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package.

Is NDC 0338-0502 included in the NDC Directory?

Yes, Clinisol with product code 0338-0502 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on August 30, 1996 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0338-0502-03?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 0338-0502-03?

The 11-digit format is 00338050203. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0338-0502-03	5-4-2	00338-0502-03

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