Ohtuvayre Suspension
NDC Package 83034-003-65

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ohtuvayre (ensifentrine) suspension is oHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. This formulation utilizes a suspension delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 83034-003 and is authorized under FDA application NDA217389.

Identification & Billing

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
11-Digit Billing Format
83034000365
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ohtuvayre
Non-Proprietary Name
Ensifentrine
Substance Name
Ensifentrine
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
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
Usage Information
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA217389
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83034-003). Click a package code to view its specific billing and regulatory data.

83034-003-60
60 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83034-003-65 identifies a specific commercial 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 Merck Sharp & Dohme Llc. This suspension is formulated for respiratory (inhalation) use and contains ensifentrine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on June 26, 2024. The current certification is valid through December 31, 2027.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83034000365. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83034-003-65
11-Digit CMS (5-4-2)
83034-0003-65

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.