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  5. NDC Package Code: 54123-114-30 Zubsolv

NDC Package 54123-114-30 Zubsolv

Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet, Orally Disintegrating - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
54123-114-30
Package Description:
3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
54123-114
Proprietary Name:
Zubsolv
Non-Proprietary Name:
Buprenorphine Hydrochloride And Naloxone Hydrochloride
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Usage Information:
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. It has little effect when taken by mouth or dissolved under the tongue. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
11-Digit NDC Billing Format:
54123011430
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1431076 - buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet
  • RxCUI: 1431076 - buprenorphine (as buprenorphine hydrochloride) 1.4 MG / naloxone (as naloxone hydrochloride dihydrate) 0.36 MG Sublingual Tablet
  • RxCUI: 1431083 - zubsolv 1.4 MG / 0.36 MG Sublingual Tablet
  • RxCUI: 1431083 - buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet [Zubsolv]
  • RxCUI: 1431083 - Zubsolv 1.4/0.36 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Orexo Us, Inc.
    Dosage Form:
    Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
    Administration Route(s):
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 11.4 mg/1
  • NALOXONE HYDROCHLORIDE 2.9 mg/1
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
  • Partial Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA204242
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-11-2014
    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.

    Frequently Asked Questions

    What is NDC 54123-114-30?

    The NDC Packaged Code 54123-114-30 is assigned to a package of 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack of Zubsolv, a human prescription drug labeled by Orexo Us, Inc.. The product's dosage form is tablet, orally disintegrating and is administered via sublingual form.

    Is NDC 54123-114 included in the NDC Directory?

    Yes, Zubsolv with product code 54123-114 is active and included in the NDC Directory. The product was first marketed by Orexo Us, Inc. on December 11, 2014 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 NDC billing unit for package 54123-114-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 54123-114-30?

    The 11-digit format is 54123011430. 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
    5-3-254123-114-305-4-254123-0114-30