Levothyroxine Sodium Capsule
NDC Package 82347-0010-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levothyroxine Sodium capsules is levothyroxine is used to treat an underactive thyroid (hypothyroidism). This formulation utilizes a capsule delivery system. Marketed by Yaral Pharma Inc., this product is identified by NDC 82347-0010 and is authorized under FDA application NDA021924.

Identification & Billing

NDC Package Code
82347-0010-4
Package Description
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code
82347-0010
11-Digit Billing Format
82347001004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levothyroxine Sodium
Non-Proprietary Name
Levothyroxine Sodium
Substance Name
Levothyroxine Sodium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOTHYROXINE SODIUM 25 ug/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Yaral Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021924
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-01-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82347-0010-4 identifies a specific commercial package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Levothyroxine Sodium, a human prescription drug labeled by Yaral Pharma Inc.. This capsule is formulated for oral use and contains levothyroxine sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Yaral Pharma Inc. on March 01, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Yaral Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82347001004. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
82347-0010-4
11-Digit CMS (5-4-2)
82347-0010-04

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.