Niva Thyroid Tablet
NDC Package 75834-310-01

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

Package Information

Niva Thyroid (thyroid, porcine) tablets is niva Thyroid tablets are indicated:1. This formulation utilizes a tablet delivery system. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-310.

Identification & Billing

NDC Package Code
75834-310-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
75834-310
11-Digit Billing Format
75834031001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Niva Thyroid
Non-Proprietary Name
Thyroid, Porcine
Substance Name
Thyroid
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
THYROID 15 mg/1
Usage Information
Niva Thyroid tablets are indicated:1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS).2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-24-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75834-310-01 identifies a specific commercial package of 100 tablet in 1 bottle of Niva Thyroid, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains thyroid 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 Nivagen Pharmaceuticals, Inc. on July 24, 2023. The current certification is valid through December 31, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834031001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
75834-310-01
11-Digit CMS (5-4-2)
75834-0310-01

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