NDC Package 70518-1191-0 Terbinafine

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
70518-1191-0
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Terbinafine
Usage Information:
Terbinafine tablets, USP 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:
70518119100
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
  • Labeler Name:
    Remedyrepack Inc.
    Sample Package:
    No
    Start Marketing Date:
    05-14-2018
    Listing Expiration Date:
    12-31-2023
    Exclude Flag:
    I
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70518-1191-130 TABLET in 1 BLISTER PACK
    70518-1191-230 TABLET in 1 BLISTER PACK
    70518-1191-345 TABLET in 1 BOTTLE, PLASTIC
    70518-1191-490 TABLET in 1 BOTTLE, PLASTIC
    70518-1191-514 TABLET in 1 BOTTLE, PLASTIC
    70518-1191-660 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70518-1191-0?

    The NDC Packaged Code 70518-1191-0 is assigned to a package of 30 tablet in 1 bottle, plastic of Terbinafine, labeled by Remedyrepack Inc.. The product's dosage form is and is administered via form.

    Is NDC 70518-1191 included in the NDC Directory?

    No, Terbinafine with product code 70518-1191 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Remedyrepack Inc. on May 14, 2018 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-1191-0?

    The 11-digit format is 70518119100. 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
    5-4-170518-1191-05-4-270518-1191-00