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  5. NDC Package Code: 16729-550-10 Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

NDC Package 16729-550-10 Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

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:
16729-550-10
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
16729-550
Proprietary Name:
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Non-Proprietary Name:
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
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:
16729055010
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:
    Accord Healthcare, Inc
    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 8 mg/1
  • NALOXONE HYDROCHLORIDE DIHYDRATE 2 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:
    ANDA209069
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-01-2020
    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.

    Frequently Asked Questions

    What is NDC 16729-550-10?

    The NDC Packaged Code 16729-550-10 is assigned to a package of 30 tablet in 1 bottle, plastic of Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate, a human prescription drug labeled by Accord Healthcare, Inc. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 16729-550 included in the NDC Directory?

    Yes, Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate with product code 16729-550 is active and included in the NDC Directory. The product was first marketed by Accord Healthcare, Inc on September 01, 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 NDC billing unit for package 16729-550-10?

    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 16729-550-10?

    The 11-digit format is 16729055010. 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
    5-3-216729-550-105-4-216729-0550-10