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  5. NDC Package Code: 0378-6993-93 Levalbuterol

NDC Package 0378-6993-93 Levalbuterol

Solution, Concentrate 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:
0378-6993-93
Package Description:
30 POUCH in 1 CARTON / 1 VIAL in 1 POUCH (0378-6993-31) / .5 mL in 1 VIAL
Product Code:
0378-6993
Proprietary Name:
Levalbuterol
Non-Proprietary Name:
Levalbuterol
Substance Name:
Levalbuterol Hydrochloride
Usage Information:
Levalbuterol inhalation solution (concentrate) 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:
00378699393
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1855389 - levalbuterol HCl concentrate 1.25 MG in 0.5 ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol 2.5 MG/ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol HCl 1.25 MG per 0.5 ML Inhalation Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
    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 1.25 mg/.5mL
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078309
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-28-2009
    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 0378-6993-93 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00378699393J7612Levalbuterol non-comp con0.5 MG0.5302.575

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-6993-93?

    The NDC Packaged Code 0378-6993-93 is assigned to a package of 30 pouch in 1 carton / 1 vial in 1 pouch (0378-6993-31) / .5 ml in 1 vial of Levalbuterol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is solution, concentrate and is administered via respiratory (inhalation) form.

    Is NDC 0378-6993 included in the NDC Directory?

    Yes, Levalbuterol with product code 0378-6993 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 28, 2009 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 0378-6993-93?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0378-6993-93?

    The 11-digit format is 00378699393. 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
    4-4-20378-6993-935-4-200378-6993-93