Ultiva Injection, Powder, Lyophilized, For Solution
NDC Package 72078-034-01

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

Package Information

Ultiva (remifentanil hydrochloride) injection is uLTIVA is indicated for intravenous (IV) administration:•As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.•For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.•As an analgesic component of monitored anesthesia care in adult patients. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 72078-034 and is authorized under FDA application NDA020630.

Identification & Billing

NDC Package Code
72078-034-01
Package Description
10 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS (72078-034-00)
Product Code
72078-034
11-Digit Billing Format
72078003401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Ultiva
Non-Proprietary Name
Remifentanil Hydrochloride
Substance Name
Remifentanil Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
REMIFENTANIL HYDROCHLORIDE 1 mg/mL
Pharmacologic Class
Usage Information
ULTIVA is indicated for intravenous (IV) administration:•As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.•For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.•As an analgesic component of monitored anesthesia care in adult patients.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020630
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-21-2023
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72078-034-01 identifies a specific commercial package of 10 vial, glass in 1 carton / 3 ml in 1 vial, glass (72078-034-00) of Ultiva, a human prescription drug labeled by Mylan Institutional Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains remifentanil hydrochloride 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 Mylan Institutional Llc on June 21, 2023. The current certification is valid through December 31, 2026.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72078003401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
72078-034-01
11-Digit CMS (5-4-2)
72078-0034-01

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