NDC Package 71858-0012-4 Tirosint

Levothyroxine Sodium Capsule Oral - 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:
71858-0012-4
Package Description:
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Tirosint
Non-Proprietary Name:
Levothyroxine Sodium
Substance Name:
Levothyroxine Sodium
Usage Information:
Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as certain types of goiters, thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.
11-Digit NDC Billing Format:
71858001204
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1923047 - levothyroxine sodium 175 MCG Oral Capsule
  • RxCUI: 1923047 - levothyroxine sodium 0.175 MG Oral Capsule
  • RxCUI: 1923049 - Tirosint 175 MCG Oral Capsule
  • RxCUI: 1923049 - levothyroxine sodium 0.175 MG Oral Capsule [Tirosint]
  • RxCUI: 1923049 - Tirosint 0.175 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ibsa Pharma Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA021924
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-01-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    71858-0012-11 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71858-0012-4?

    The NDC Packaged Code 71858-0012-4 is assigned to a package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Tirosint, a human prescription drug labeled by Ibsa Pharma Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package.

    Is NDC 71858-0012 included in the NDC Directory?

    Yes, Tirosint with product code 71858-0012 is active and included in the NDC Directory. The product was first marketed by Ibsa Pharma Inc. on March 01, 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 NDC billing unit for package 71858-0012-4?

    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 3.

    What is the 11-digit format for NDC 71858-0012-4?

    The 11-digit format is 71858001204. 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
    5-4-171858-0012-45-4-271858-0012-04