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  5. NDC Package Code: 0264-4500-00 Plenamine

NDC Package 0264-4500-00 Plenamine

Lysine - 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:
0264-4500-00
Package Description:
8 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER
Product Code:
0264-4500
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
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.
11-Digit NDC Billing Format:
00264450000
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    B. Braun Medical Inc.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ALANINE 2.17 g/100mL
  • ARGININE 1.47 g/100mL
  • ASPARTIC ACID 434 mg/100mL
  • GLUTAMIC ACID 749 mg/100mL
  • GLYCINE 1.04 g/100mL
  • HISTIDINE 894 mg/100mL
  • ISOLEUCINE 749 mg/100mL
  • LEUCINE 1.04 g/100mL
  • LYSINE ACETATE 1.18 g/100mL
  • METHIONINE 749 mg/100mL
  • PHENYLALANINE 1.04 g/100mL
  • PROLINE 894 mg/100mL
  • SERINE 592 mg/100mL
  • THREONINE 749 mg/100mL
  • TRYPTOPHAN 250 mg/100mL
  • TYROSINE 39 mg/100mL
  • VALINE 960 mg/100mL
    • Pharmacologic Class(es):
  • Amino Acid - [EPC] (Established Pharmacologic Class)
  • Amino Acids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA091112
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-28-2018
    Listing Expiration Date:
    12-31-2024
    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
    0264-4500-054 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0264-4500-00?

    The NDC Packaged Code 0264-4500-00 is assigned to a package of 8 container in 1 case / 1000 ml in 1 container of Plenamine, a human prescription drug labeled by B. Braun Medical Inc.. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 0264-4500 included in the NDC Directory?

    Yes, Plenamine with product code 0264-4500 is active and included in the NDC Directory. The product was first marketed by B. Braun Medical Inc. on September 28, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0264-4500-00?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0264-4500-00?

    The 11-digit format is 00264450000. 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
    4-4-20264-4500-005-4-200264-4500-00