Olinvyk Injection, Solution
NDC Package 71308-021-10

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

Package Information

Olinvyk (oliceridine) injection is oLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:Have not been tolerated, or are not expected to be toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia.The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation. This formulation utilizes a injection, solution delivery system. Marketed by Trevena, Inc., this product is identified by NDC 71308-021 and is authorized under FDA application NDA210730.

Identification & Billing

NDC Package Code
71308-021-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01)
Product Code
71308-021
11-Digit Billing Format
71308002110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olinvyk
Non-Proprietary Name
Oliceridine
Substance Name
Oliceridine
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
OLICERIDINE 2 mg/2mL
Usage Information
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:Have not been tolerated, or are not expected to be toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia.The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation. [see Warnings and Precautions (5.5].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Trevena, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210730
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-07-2020
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71308-021-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose (71308-021-01) of Olinvyk, a human prescription drug labeled by Trevena, Inc.. This injection, solution is formulated for intravenous use and contains oliceridine 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 Trevena, Inc. on August 07, 2020. The current certification is valid through December 31, 2027.

How is this Trevena, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71308002110. 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)
71308-021-10
11-Digit CMS (5-4-2)
71308-0021-10

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