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  5. NDC Package Code: 50383-294-93 Buprenorphine And Naloxone

NDC Package 50383-294-93 Buprenorphine And Naloxone

Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet Sublingual - 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:
50383-294-93
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
50383-294
Proprietary Name:
Buprenorphine And Naloxone
Non-Proprietary Name:
Buprenorphine Hydrochloride And Naloxone Hydrochloride
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Usage Information:
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
11-Digit NDC Billing Format:
50383029493
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 351266 - buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet
  • RxCUI: 351266 - buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet
  • RxCUI: 351266 - buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet
  • RxCUI: 351267 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet
  • RxCUI: 351267 - buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Akorn Operating Company Llc (dba Akorn)
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 2 mg/1
  • NALOXONE HYDROCHLORIDE .5 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:
    ANDA204431
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-07-2016
    End Marketing Date:
    03-31-2025
    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 50383-294-93?

    The NDC Packaged Code 50383-294-93 is assigned to a package of 30 tablet in 1 bottle, plastic of Buprenorphine And Naloxone, a human prescription drug labeled by Akorn Operating Company Llc (dba Akorn). The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 50383-294 included in the NDC Directory?

    Yes, Buprenorphine And Naloxone with product code 50383-294 is active and included in the NDC Directory. The product was first marketed by Akorn Operating Company Llc (dba Akorn) on January 07, 2016.

    What is the NDC billing unit for package 50383-294-93?

    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 30.

    What is the 11-digit format for NDC 50383-294-93?

    The 11-digit format is 50383029493. 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
    5-3-250383-294-935-4-250383-0294-93