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  5. NDC Package Code: 70518-1007-0 Buprenorphine Hcl And Naloxone Hcl

NDC Package 70518-1007-0 Buprenorphine Hcl And Naloxone Hcl

Buprenorphine And Naloxone 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:
70518-1007-0
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
70518-1007
Proprietary Name:
Buprenorphine Hcl And Naloxone Hcl
Non-Proprietary Name:
Buprenorphine And Naloxone
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
Usage Information:
Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
11-Digit NDC Billing Format:
70518100700
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack 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 2 mg/1
  • NALOXONE HYDROCHLORIDE DIHYDRATE .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:
    ANDA203136
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-08-2018
    Listing Expiration Date:
    12-31-2025
    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 70518-1007-0?

    The NDC Packaged Code 70518-1007-0 is assigned to a package of 30 tablet in 1 blister pack of Buprenorphine Hcl And Naloxone Hcl, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 70518-1007 included in the NDC Directory?

    Yes, Buprenorphine Hcl And Naloxone Hcl with product code 70518-1007 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on February 08, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-1007-0?

    The 11-digit format is 70518100700. 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 5-4-1 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
    5-4-170518-1007-05-4-270518-1007-00