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  5. NDC Package Code: 43386-680-01 Pentazocine Hydrochloride And Naloxone Hydrochloride

NDC Package 43386-680-01 Pentazocine Hydrochloride And Naloxone Hydrochloride

Tablet Oral - 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:
43386-680-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
43386-680
Proprietary Name:
Pentazocine Hydrochloride And Naloxone Hydrochloride
Non-Proprietary Name:
Pentazocine Hydrochloride And Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride; Pentazocine Hydrochloride
Usage Information:
Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia
11-Digit NDC Billing Format:
43386068001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 312289 - pentazocine 50 MG / naloxone 0.5 MG Oral Tablet
  • RxCUI: 312289 - naloxone 0.5 MG / pentazocine 50 MG Oral Tablet
  • RxCUI: 312289 - naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NALOXONE HYDROCHLORIDE .5 mg/1
  • PENTAZOCINE HYDROCHLORIDE 50 mg/1
    • Pharmacologic Class(es):
  • Competitive Opioid Antagonists - [MoA] (Mechanism of Action)
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
  • Partial Opioid Agonist/Antagonist - [EPC] (Established Pharmacologic Class)
  • Partial Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA075735
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-11-2011
    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 43386-680-01?

    The NDC Packaged Code 43386-680-01 is assigned to a package of 100 tablet in 1 bottle of Pentazocine Hydrochloride And Naloxone Hydrochloride, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 43386-680 included in the NDC Directory?

    Yes, Pentazocine Hydrochloride And Naloxone Hydrochloride with product code 43386-680 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on May 11, 2011 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 NDC billing unit for package 43386-680-01?

    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 100.

    What is the 11-digit format for NDC 43386-680-01?

    The 11-digit format is 43386068001. 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
    5-3-243386-680-015-4-243386-0680-01