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  5. NDC Package Code: 83034-003-65 Ohtuvayre

NDC Package 83034-003-65 Ohtuvayre

Ensifentrine Suspension Respiratory (inhalation) - 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:
83034-003-65
Package Description:
60 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE
Product Code:
83034-003
Proprietary Name:
Ohtuvayre
Non-Proprietary Name:
Ensifentrine
Substance Name:
Ensifentrine
Usage Information:
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
11-Digit NDC Billing Format:
83034000365
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Verona Pharma, Inc.
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s):
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s):
ENSIFENTRINE 3 mg/2.5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA217389
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-26-2024
Listing Expiration Date:
12-31-2026
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
83034-003-6060 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83034-003-65?

The NDC Packaged Code 83034-003-65 is assigned to a package of 60 pouch in 1 carton / 5 ampule in 1 pouch (83034-003-05) / 2.5 ml in 1 ampule of Ohtuvayre, a human prescription drug labeled by Verona Pharma, Inc.. The product's dosage form is suspension and is administered via respiratory (inhalation) form.

Is NDC 83034-003 included in the NDC Directory?

Yes, Ohtuvayre with product code 83034-003 is active and included in the NDC Directory. The product was first marketed by Verona Pharma, Inc. on June 26, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83034-003-65?

The 11-digit format is 83034000365. 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
5-3-283034-003-655-4-283034-0003-65