Nyata
NDC Package 0316-1010-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nyata is a . Marketed by Crown Laboratories, this product is identified by NDC 0316-1010 and is authorized under FDA application ANDA065138.

Identification & Billing

NDC Package Code
0316-1010-01
Package Description
1 KIT in 1 KIT * 3 BOTTLE, PLASTIC in 1 KIT (0316-0187-15) / 15 g in 1 BOTTLE, PLASTIC * 1 TUBE in 1 KIT / 114 g in 1 TUBE
Product Code
0316-1010
11-Digit Billing Format
00316101001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Nyata
Dosage Form
-

Regulatory & Marketing

Labeler Name
Crown Laboratories
FDA Application #
ANDA065138
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2015
End Marketing Date
10-03-2016
Listing Expiration
10-03-2016
Exclude Flag
D
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 0316-1010-01 identifies a specific commercial package of 1 kit in 1 kit * 3 bottle, plastic in 1 kit (0316-0187-15) / 15 g in 1 bottle, plastic * 1 tube in 1 kit / 114 g in 1 tube of Nyata, labeled by Crown Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Crown Laboratories on December 17, 2015. The current certification is valid through October 03, 2016.

How is this Crown Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00316101001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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 (4-4-2)
0316-1010-01
11-Digit CMS (5-4-2)
00316-1010-01

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