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  5. NDC Package Code: 62450-003-01 Vamorolone

NDC Package 62450-003-01 Vamorolone

Suspension - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
62450-003-01
Package Description:
100 mL in 1 BOTTLE
Product Code:
62450-003
Non-Proprietary Name:
Vamorolone
Substance Name:
Vamorolone
Usage Information:
CONTRAINDICATIONS AGAMREE is contraindicated in patients with known hypersensitivity to vamorolone or to any of the inactive ingredients of AGAMREE. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy [see Warnings and Precautions (5.13)].
11-Digit NDC Billing Format:
62450000301
Product Type:
Drug For Further Processing
Labeler Name:
Purna Pharmaceuticals Nv
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Active Ingredient(s):
  • VAMOROLONE 40 mg/mL
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    11-23-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 62450-003-01?

    The NDC Packaged Code 62450-003-01 is assigned to an UNFINISHED drug package of 100 ml in 1 bottle of Vamorolone, drug for further processing labeled by Purna Pharmaceuticals Nv. The product's dosage form is suspension and is administered via form.

    Is NDC 62450-003 included in the NDC Directory?

    Yes, Vamorolone is an UNFINISHED PRODUCT with code 62450-003 that is active and included in the NDC Directory. The product was first marketed by Purna Pharmaceuticals Nv on November 23, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 62450-003-01?

    The 11-digit format is 62450000301. 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
    5-3-262450-003-015-4-262450-0003-01