Levonorgestrel
NDC Package 0536-1142-63

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.

Levonorgestrel is •take as soon as possible within 72 hours (3 days) after unprotected sex. Marketed by Rugby Laboratories, this product is identified by NDC 0536-1142 and is authorized under FDA application ANDA202635.

Identification & Billing

NDC Package Code
0536-1142-63
Package Description
1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
0536-1142
11-Digit Billing Format
00536114263
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Levonorgestrel
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
Rugby Laboratories
FDA Application #
ANDA202635
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2017
End Marketing Date
11-01-2017
Listing Expiration
11-01-2017
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 0536-1142-63 identifies a specific commercial package of 1 blister pack in 1 carton / 1 tablet in 1 blister pack of Levonorgestrel, labeled by Rugby 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 Rugby Laboratories on November 01, 2017. The current certification is valid through November 01, 2017.

How is this Rugby Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536114263. 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 (4-4-2)
0536-1142-63
11-Digit CMS (5-4-2)
00536-1142-63

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