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  5. NDC Package Code: 71308-021-10 Olinvyk

NDC Package 71308-021-10 Olinvyk

Oliceridine Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
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
Proprietary Name:
Olinvyk
Non-Proprietary Name:
Oliceridine
Substance Name:
Oliceridine
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].
11-Digit NDC Billing Format:
71308002110
NDC to RxNorm Crosswalk:
  • RxCUI: 2392234 - oliceridine 1 MG in 1 ML Injection
  • RxCUI: 2392234 - 1 ML oliceridine 1 MG/ML Injection
  • RxCUI: 2392234 - 1 ML oliceridine 1 MG/ML (as oliceridine fumarate 1.3 MG /1 ML) Injection
  • RxCUI: 2392234 - oliceridine 1 MG per 1 ML Injection
  • RxCUI: 2392239 - Olinvyk 1 MG in 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Trevena, Inc.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • OLICERIDINE 2 mg/2mL
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA210730
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-07-2020
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 71308-021-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    71308002110C9101Inj, oliceridine 0.1 mg0.1 MG21020200

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71308-021-10?

    The NDC Packaged Code 71308-021-10 is assigned to a 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.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 71308-021 included in the NDC Directory?

    Yes, Olinvyk with product code 71308-021 is active and included in the NDC Directory. The product was first marketed by Trevena, Inc. on August 07, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71308-021-10?

    The 11-digit format is 71308002110. 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
    5-3-271308-021-105-4-271308-0021-10