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  5. NDC Package Code: 35573-443-25 Levalbuterol

NDC Package 35573-443-25 Levalbuterol

Levalbuterol Hydrochloride Solution Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
35573-443-25
Package Description:
25 POUCH in 1 CARTON / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code:
35573-443
Proprietary Name:
Levalbuterol
Non-Proprietary Name:
Levalbuterol Hydrochloride
Substance Name:
Levalbuterol Hydrochloride
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:
35573044325
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:
    Burel Pharmaceuticals, Llc
    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 HYDROCHLORIDE .31 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:
    ANDA203653
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2021
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 35573-443-25 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    35573044325J7612Levalbuterol non-comp con0.5 MG3250.6215.5
    35573044325J7614Levalbuterol non-comp unit0.5 MG3250.6215.5

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 35573-443-25?

    The NDC Packaged Code 35573-443-25 is assigned to a package of 25 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 ml in 1 vial, single-dose of Levalbuterol, a human prescription drug labeled by Burel Pharmaceuticals, Llc. The product's dosage form is solution and is administered via respiratory (inhalation) form.

    Is NDC 35573-443 included in the NDC Directory?

    Yes, Levalbuterol with product code 35573-443 is active and included in the NDC Directory. The product was first marketed by Burel Pharmaceuticals, Llc on April 01, 2021 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 35573-443-25?

    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 35573-443-25?

    The 11-digit format is 35573044325. 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
    5-3-235573-443-255-4-235573-0443-25