1. Home
  2. Labeler Index
  3. Dr. Reddy�s Laboratories, Inc.
  4. 43598-410
  5. NDC Package Code: 43598-410-25 Levalbuterol Inhalation

NDC Package 43598-410-25 Levalbuterol Inhalation

Levalbuterol Inhalation 0.63mg/3ml Solution Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
43598-410-25
Package Description:
5 POUCH in 1 CARTON / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL
Product Code:
43598-410
Proprietary Name:
Levalbuterol Inhalation
Non-Proprietary Name:
Levalbuterol Inhalation 0.63mg/3ml
Substance Name:
Levalbuterol
Usage Information:
Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
11-Digit NDC Billing Format:
43598041025
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 242754 - levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 0.417 MG/ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution
  • RxCUI: 311286 - levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution
  • RxCUI: 311286 - levalbuterol 0.21 MG/ML Inhalation Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddy�s Laboratories, 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):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • LEVALBUTEROL .63 mg/3mL
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078171
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-16-2014
    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.

    Frequently Asked Questions

    What is NDC 43598-410-25?

    The NDC Packaged Code 43598-410-25 is assigned to a package of 5 pouch in 1 carton / 5 vial in 1 pouch (43598-410-05) / 3 ml in 1 vial of Levalbuterol Inhalation, a human prescription drug labeled by Dr. Reddy�s Laboratories, Inc.. The product's dosage form is solution and is administered via respiratory (inhalation) form.

    Is NDC 43598-410 included in the NDC Directory?

    Yes, Levalbuterol Inhalation with product code 43598-410 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy�s Laboratories, Inc. on September 16, 2014 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 43598-410-25?

    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 43598-410-25?

    The 11-digit format is 43598041025. 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 5-3-2 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
    5-3-243598-410-255-4-243598-0410-25