Premasol - Sulfite-free (amino Acid) Injection, Solution
NDC Package 0338-1130-06

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

Package Information

Premasol - Sulfite-free (amino Acid) (leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride) injection is 6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections are indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Company, this product is identified by NDC 0338-1130 and is authorized under FDA application ANDA075880.

Identification & Billing

NDC Package Code
0338-1130-06
Package Description
2000 mL in 1 BAG
Product Code
0338-1130
11-Digit Billing Format
00338113006
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: 801395 - alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution
  • RxCUI: 801398 - PremaSol 6 % Injectable Solution
  • RxCUI: 801398 - alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution [PremaSol]
  • RxCUI: 801398 - PremaSol 6 % Amino Acids Injectable Solution
  • RxCUI: 801403 - alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Premasol - Sulfite-free (amino Acid)
Non-Proprietary Name
Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride
Substance Name
Alanine; Arginine; Aspartic Acid; Cysteine Hydrochloride; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; 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
6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections are indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL - sulfite-free (Amino Acid) Injections is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See Dosage and Administration for additional information.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
ANDA075880
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2003
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0338-1130). Click a package code to view its specific billing and regulatory data.

0338-1130-03
500 mL in 1 BAG
0338-1130-04
1000 mL in 1 BAG

* 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 0338-1130-06 identifies a specific commercial package of 2000 ml in 1 bag of Premasol - Sulfite-free (amino Acid), a human prescription drug labeled by Baxter Healthcare Company. 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; cysteine hydrochloride; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; taurine; 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 Company on June 19, 2003. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338113006. 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)
0338-1130-06
11-Digit CMS (5-4-2)
00338-1130-06

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