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  5. NDC Package Code: 0338-1130-04 Premasol - Sulfite-free (amino Acid)

NDC Package 0338-1130-04 Premasol - Sulfite-free (amino Acid)

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
0338-1130-04
Package Description:
1000 mL in 1 BAG
Product Code:
0338-1130
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
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.
11-Digit NDC Billing Format:
00338113004
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
1000 ML
NDC to 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
    • 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):
  • ALANINE .54 g/100mL
  • ARGININE 1.2 g/100mL
  • ASPARTIC ACID .32 g/100mL
  • CYSTEINE HYDROCHLORIDE .016 g/100mL
  • GLUTAMIC ACID .5 g/100mL
  • GLYCINE .36 g/100mL
  • HISTIDINE .48 g/100mL
  • ISOLEUCINE .82 g/100mL
  • LEUCINE 1.4 g/100mL
  • LYSINE ACETATE .82 g/100mL
  • METHIONINE .34 g/100mL
  • PHENYLALANINE .48 g/100mL
  • PROLINE .68 g/100mL
  • SERINE .38 g/100mL
  • TAURINE 25 mg/100mL
  • THREONINE .42 g/100mL
  • TRYPTOPHAN .2 g/100mL
  • TYROSINE .24 g/100mL
  • VALINE .78 g/100mL
    • Pharmacologic Class(es):
  • Amino Acid - [EPC] (Established Pharmacologic Class)
  • Amino Acids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA075880
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-19-2003
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    0338-1130-03500 mL in 1 BAG
    0338-1130-062000 mL in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-1130-04?

    The NDC Packaged Code 0338-1130-04 is assigned to a package of 1000 ml in 1 bag of Premasol - Sulfite-free (amino Acid), 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 1000 billable units per package.

    Is NDC 0338-1130 included in the NDC Directory?

    Yes, Premasol - Sulfite-free (amino Acid) with product code 0338-1130 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on June 19, 2003 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0338-1130-04?

    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 1000.

    What is the 11-digit format for NDC 0338-1130-04?

    The 11-digit format is 00338113004. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20338-1130-045-4-200338-1130-04