NDC Package 0054-4146-22 Clotrimazole

Lozenge Oral; Topical - View Billable Units, 11-Digit Format, RxNorm

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:
0054-4146-22
Package Description:
70 LOZENGE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Clotrimazole
Non-Proprietary Name:
Clotrimazole
Substance Name:
Clotrimazole
Usage Information:
Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.
11-Digit NDC Billing Format:
00054414622
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
70 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 309371 - clotrimazole 10 MG Oral Lozenge
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmacuticals Usa Usa Inc.
    Dosage Form:
    Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA076387
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-29-2004
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0054-4146-23140 LOZENGE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0054-4146-22?

    The NDC Packaged Code 0054-4146-22 is assigned to a package of 70 lozenge in 1 bottle, plastic of Clotrimazole, a human prescription drug labeled by Hikma Pharmacuticals Usa Usa Inc.. The product's dosage form is lozenge and is administered via oral; topical form.

    Is NDC 0054-4146 included in the NDC Directory?

    Yes, Clotrimazole with product code 0054-4146 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmacuticals Usa Usa Inc. on July 29, 2004 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 0054-4146-22?

    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 70.

    What is the 11-digit format for NDC 0054-4146-22?

    The 11-digit format is 00054414622. 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 4-4-2 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
    4-4-20054-4146-225-4-200054-4146-22