Plenamine Solution
NDC Package 0264-4500-05

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

Plenamine (lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine) solution is plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This formulation utilizes a solution delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-4500 and is authorized under FDA application ANDA091112.

Identification & Billing

NDC Package Code
0264-4500-05
Package Description
4 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER
Product Code
0264-4500
11-Digit Billing Format
00264450005
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1601982 - Plenamine 15 % Injectable Solution
  • RxCUI: 1601982 - 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 [Plenamine]
  • RxCUI: 1601982 - Plenamine 15 % Amino Acids Injection
  • 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

Clinical Specifications

Proprietary Name
Plenamine
Non-Proprietary Name
Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, 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
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
Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when:—   Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; —   Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; —   Tube feeding methods alone cannot provide adequate nutrition.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091112
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-28-2018
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 (0264-4500). Click a package code to view its specific billing and regulatory data.

0264-4500-00
8 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER

* 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 0264-4500-05 identifies a specific commercial package of 4 container in 1 case / 2000 ml in 1 container of Plenamine, a human prescription drug labeled by B. Braun Medical Inc.. This 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 B. Braun Medical Inc. on September 28, 2018. The current certification is valid through December 31, 2027.

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: 00264450005. 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)
0264-4500-05
11-Digit CMS (5-4-2)
00264-4500-05

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