Trophamine Solution
NDC Package 0264-1933-10

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

Package Information

Trophamine (isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine) solution is trophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. This formulation utilizes a solution delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-1933 and is authorized under FDA application NDA019018.

Identification & Billing

NDC Package Code
0264-1933-10
Package Description
12 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER
Product Code
0264-1933
11-Digit Billing Format
00264193310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1189640 - TrophAmine 10 % Injectable Solution
  • RxCUI: 1189640 - alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML Injectable Solution [Trophamine 10 %]
  • RxCUI: 1189640 - Alanine 5.4 MG/ML / Arginine 12 MG/ML / Aspartate 3.2 MG/ML / Cysteine 0.24 MG/ML / Glutamate 5 MG/ML / Glycine 3.6 MG/ML / Histidine 4.8 MG/ML / Isoleucine 8.2 MG/ML / Leucine 1.4 MG/ML / Lysine 1.2 MG/ML / Methionine 3.4 MG/ML / Phenylalanine 4.8 MG/ML / Proline 6.8 MG/ML / Serine 3.8 MG/ML / Sodium Acetate 0.097 MEQ/ML / NaCl 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / Taurine 0.25 MG/ML / Threonine 4.2 MG/ML / Tryptophan 2 MG/ML / Tyrosine 2.84 MG/ML / Valine 7.8 MG/ML Injectable Solution [Trophamine 10 %]
  • RxCUI: 1189640 - Trophamine 10 % (alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML) Injectable Solution
  • RxCUI: 800611 - alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.24 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 1.4 MG/ML / lysine 1.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / sodium acetate 0.097 MEQ/ML / sodium chloride 0.003 MEQ/ML / sodium metabisulfite 0.5 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.84 MG/ML / valine 7.8 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Trophamine
Non-Proprietary Name
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine Hydrochloride, Histidine, Tyrosine, N-acetyl-tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid, And Taurine
Substance Name
Acetyl L-tyrosine; 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
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
TrophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine® is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients 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 WARNINGS, PRECAUTIONS, Pediatric Use, AND DOSAGE AND ADMINISTRATION.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019018
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-27-2020
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0264-1933-10 identifies a specific commercial package of 12 container in 1 case / 500 ml in 1 container of Trophamine, a human prescription drug labeled by B. Braun Medical Inc.. This solution is formulated for intravenous use and contains acetyl l-tyrosine; 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 B. Braun Medical Inc. on October 27, 2020. 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: 00264193310. 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:

10-Digit Format (4-4-2)
0264-1933-10
11-Digit CMS (5-4-2)
00264-1933-10

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