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  5. NDC Package Code: 0362-0101-10 Oraverse

NDC Package 0362-0101-10 Oraverse

Phentolamine Mesylate Injection, Solution Submucosal - 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:
0362-0101-10
Package Description:
10 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE
Product Code:
0362-0101
Proprietary Name:
Oraverse
Non-Proprietary Name:
Phentolamine Mesylate
Substance Name:
Phentolamine Mesylate
Usage Information:
OraVerse is contraindicated in patients with:Hypersensitivity to the active substance or to any ingredients in the formulation
11-Digit NDC Billing Format:
00362010110
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Septodont, Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
Submucosal - Administration beneath the mucous membrane.
Active Ingredient(s):
PHENTOLAMINE MESYLATE .235 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA022159
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-01-2011
Listing Expiration Date:
12-31-2025
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 0362-0101-10?

The NDC Packaged Code 0362-0101-10 is assigned to a package of 10 cartridge in 1 carton / 1.7 ml in 1 cartridge of Oraverse, a human prescription drug labeled by Septodont, Inc.. The product's dosage form is injection, solution and is administered via submucosal form.

Is NDC 0362-0101 included in the NDC Directory?

Yes, Oraverse with product code 0362-0101 is active and included in the NDC Directory. The product was first marketed by Septodont, Inc. on June 01, 2011 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 0362-0101-10?

The 11-digit format is 00362010110. 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
4-4-20362-0101-105-4-200362-0101-10