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  5. NDC Package Code: 82982-046-42 Terbinafine

NDC Package 82982-046-42 Terbinafine

Terbinafine 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:
82982-046-42
Package Description:
42 TABLET in 1 BOTTLE
Product Code:
82982-046
Proprietary Name:
Terbinafine
Non-Proprietary Name:
Terbinafine Hydrochloride
Substance Name:
Terbinafine Hydrochloride
Usage Information:
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.
11-Digit NDC Billing Format:
82982004642
NDC to RxNorm Crosswalk:
  • RxCUI: 313222 - terbinafine HCl 250 MG Oral Tablet
  • RxCUI: 313222 - terbinafine 250 MG Oral Tablet
  • RxCUI: 313222 - terbinafine (as terbinafine HCl) 250 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmasource Meds, Llc
    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):
  • TERBINAFINE HYDROCHLORIDE 250 mg/1
    • Pharmacologic Class(es):
  • Allylamine Antifungal - [EPC] (Established Pharmacologic Class)
  • Allylamine - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA078297
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-15-2023
    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 82982-046-42?

    The NDC Packaged Code 82982-046-42 is assigned to a package of 42 tablet in 1 bottle of Terbinafine, a human prescription drug labeled by Pharmasource Meds, Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 82982-046 included in the NDC Directory?

    Yes, Terbinafine with product code 82982-046 is active and included in the NDC Directory. The product was first marketed by Pharmasource Meds, Llc on March 15, 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 11-digit format for NDC 82982-046-42?

    The 11-digit format is 82982004642. 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
    5-3-282982-046-425-4-282982-0046-42