1. Home
  2. Labeler Index
  3. Ingenus Pharmaceuticals, Llc
  4. 50742-365
  5. NDC Package Code: 50742-365-30 Buprenorphine And Naloxone

NDC Package 50742-365-30 Buprenorphine And Naloxone

Film Buccal; 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:
50742-365-30
Package Description:
30 POUCH in 1 CARTON / 1 FILM in 1 POUCH (50742-365-01)
Product Code:
50742-365
Proprietary Name:
Buprenorphine And Naloxone
Non-Proprietary Name:
Buprenorphine And Naloxone
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Usage Information:
Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
11-Digit NDC Billing Format:
50742036530
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: 1010604 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Buccal Film
  • RxCUI: 1307061 - buprenorphine HCl 12 MG / naloxone HCl 3 MG Sublingual Film
  • RxCUI: 1307061 - buprenorphine 12 MG / naloxone 3 MG Sublingual Film
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ingenus Pharmaceuticals, Llc
    Dosage Form:
    Film - A thin layer or coating.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 12 mg/1
  • NALOXONE HYDROCHLORIDE 3 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:
    ANDA212756
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-29-2023
    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 50742-365-30?

    The NDC Packaged Code 50742-365-30 is assigned to a package of 30 pouch in 1 carton / 1 film in 1 pouch (50742-365-01) of Buprenorphine And Naloxone, a human prescription drug labeled by Ingenus Pharmaceuticals, Llc. The product's dosage form is film and is administered via buccal; sublingual form.

    Is NDC 50742-365 included in the NDC Directory?

    Yes, Buprenorphine And Naloxone with product code 50742-365 is active and included in the NDC Directory. The product was first marketed by Ingenus Pharmaceuticals, Llc on August 29, 2023 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 50742-365-30?

    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 30.

    What is the 11-digit format for NDC 50742-365-30?

    The 11-digit format is 50742036530. 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
    5-3-250742-365-305-4-250742-0365-30