New Day
NDC Package 76413-357-01

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 inactivated by the FDA.

New Day is •take as soon as possible within 72 hours (3 days) after unprotected sex. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-357 and is authorized under FDA application ANDA207976.

Identification & Billing

NDC Package Code
76413-357-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
76413-357
11-Digit Billing Format
76413035701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
New Day
Dosage Form
-
Usage Information
•take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. •if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

Regulatory & Marketing

Labeler Name
Central Texas Community Health Centers
FDA Application #
ANDA207976
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-11-2016
Listing Expiration
12-31-2020
Exclude Flag
I
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 76413-357-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 tablet in 1 blister pack of New Day, labeled by Central Texas Community Health Centers. 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 Central Texas Community Health Centers on March 11, 2016. The current certification is valid through December 31, 2020.

How is this Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413035701. 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)
76413-357-01
11-Digit CMS (5-4-2)
76413-0357-01

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