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  5. NDC Package Code: 50458-028-03 Spravato

NDC Package 50458-028-03 Spravato

Esketamine Hydrochloride Solution Nasal - 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:
50458-028-03
Package Description:
3 BLISTER PACK in 1 KIT / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
Product Code:
50458-028
Proprietary Name:
Spravato
Non-Proprietary Name:
Esketamine Hydrochloride
Substance Name:
Esketamine Hydrochloride
Usage Information:
This medication is used to treat depression. It may improve your mood and restore your interest in daily living. Esketamine is used with an antidepressant medication that you take by mouth.
11-Digit NDC Billing Format:
50458002803
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: 2119381 - esketamine 140 MG/mL Nasal Spray
  • RxCUI: 2119381 - esketamine 140 MG/ML Nasal Spray
  • RxCUI: 2119387 - Spravato 28 MG in 0.2 mL Nasal Spray
  • RxCUI: 2119387 - esketamine 140 MG/ML Nasal Spray [Spravato]
  • RxCUI: 2119387 - Spravato 140 MG/ML Nasal Spray
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Pharmaceuticals 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):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • ESKETAMINE HYDROCHLORIDE 28 mg/.2mL
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA211243
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-05-2019
    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
    50458-028-022 BLISTER PACK in 1 KIT / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-028-03?

    The NDC Packaged Code 50458-028-03 is assigned to a package of 3 blister pack in 1 kit / 1 vial, single-use in 1 blister pack / .2 ml in 1 vial, single-use (50458-028-00) of Spravato, a human prescription drug labeled by Janssen Pharmaceuticals Inc.. The product's dosage form is solution and is administered via nasal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 50458-028 included in the NDC Directory?

    Yes, Spravato with product code 50458-028 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals Inc. on March 05, 2019 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 50458-028-03?

    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 50458-028-03?

    The 11-digit format is 50458002803. 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
    5-3-250458-028-035-4-250458-0028-03