Ohtuvayre Suspension
NDC Package 83034-003-60
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
- RxCUI: 2687221 - ensifentrine 3 MG in 2.5 ML Inhalation Suspension
- RxCUI: 2687221 - ensifentrine 1.2 MG/ML Inhalation Suspension
- RxCUI: 2687221 - ensifentrine 3 MG per 2.5 ML Inhalation Suspension
- RxCUI: 2687226 - Ohtuvayre 3 MG in 2.5 ML Inhalation Suspension
- RxCUI: 2687226 - ensifentrine 1.2 MG/ML Inhalation Suspension [Ohtuvayre]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 83034 - Merck Sharp & Dohme Llc
- 83034-003 - Ohtuvayre
- 83034-003-60 - 60 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE
- 83034-003 - Ohtuvayre
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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.
* 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 83034-003-60 identifies a specific commercial package of 60 pouch in 1 carton / 1 ampule in 1 pouch (83034-003-01) / 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: 83034000360. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
