Levothyroxine Sodium Injection, Powder, Lyophilized, For Solution
NDC Package 70710-1835-1

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

Package Information

Levothyroxine Sodium injection is levothyroxine is used to treat an underactive thyroid (hypothyroidism). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1835 and is authorized under FDA application ANDA217066.

Identification & Billing

NDC Package Code
70710-1835-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
70710-1835
11-Digit Billing Format
70710183501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levothyroxine Sodium
Non-Proprietary Name
Levothyroxine Sodium
Substance Name
Levothyroxine Sodium Anhydrous
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LEVOTHYROXINE SODIUM ANHYDROUS 500 ug/5mL
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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217066
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2024
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0650
Source: PDAC
INJECTION, LEVOTHYROXINE SODIUM, NOT OTHERWISE SPECIFIED, 10 MCG
HCPCS Dosage 10 MCG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 70710-1835-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Levothyroxine Sodium, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains levothyroxine sodium anhydrous 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 Zydus Pharmaceuticals Usa Inc. on November 01, 2024. The current certification is valid through December 31, 2026.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710183501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
70710-1835-1
11-Digit CMS (5-4-2)
70710-1835-01

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