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  5. NDC Package Code: 58118-0176-8 Buprenorphine Hcl

NDC Package 58118-0176-8 Buprenorphine Hcl

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:
58118-0176-8
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
58118-0176
Proprietary Name:
Buprenorphine Hcl
Non-Proprietary Name:
Buprenorphine Hcl
Substance Name:
Buprenorphine Hydrochloride
Usage Information:
Buprenorphine is used to treat dependence/addiction to opioids. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It 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:
58118017608
NDC to RxNorm Crosswalk:
  • RxCUI: 351264 - buprenorphine HCl 2 MG Sublingual Tablet
  • RxCUI: 351264 - buprenorphine 2 MG Sublingual Tablet
  • RxCUI: 351264 - buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet
  • RxCUI: 351265 - buprenorphine HCl 8 MG Sublingual Tablet
  • RxCUI: 351265 - buprenorphine 8 MG Sublingual Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Clinical Solutions Wholesale, Llc
    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
    • Pharmacologic Class(es):
  • 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:
    ANDA078633
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-08-2009
    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 58118-0176-8?

    The NDC Packaged Code 58118-0176-8 is assigned to a package of 30 tablet in 1 blister pack of Buprenorphine Hcl, a human prescription drug labeled by Clinical Solutions Wholesale, Llc. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 58118-0176 included in the NDC Directory?

    Yes, Buprenorphine Hcl with product code 58118-0176 is active and included in the NDC Directory. The product was first marketed by Clinical Solutions Wholesale, Llc on October 08, 2009 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 58118-0176-8?

    The 11-digit format is 58118017608. 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
    5-4-158118-0176-85-4-258118-0176-08