Levonorgestrel
NDC Package 40032-620-30

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.

Levonorgestrel is tablet, 1.5 mg is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-620 and is authorized under FDA application ANDA202508.

Identification & Billing

NDC Package Code
40032-620-30
Package Description
1 TABLET in 1 CARTON
Product Code
40032-620
11-Digit Billing Format
40032062030
RxNorm Crosswalk
RxCUI: 483325 - levonorgestrel 1.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Levonorgestrel
Dosage Form
-
Usage Information
Levonorgestrel Tablet, 1.5 mg is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel Tablet is not indicated for routine use as a contraceptive.

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
FDA Application #
ANDA202508
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-22-2013
Listing Expiration
12-31-2017
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 40032-620-30 identifies a specific commercial package of 1 tablet in 1 carton of Levonorgestrel, labeled by Novel Laboratories, Inc.. 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 Novel Laboratories, Inc. on February 22, 2013. The current certification is valid through December 31, 2017.

How is this Novel Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032062030. 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)
40032-620-30
11-Digit CMS (5-4-2)
40032-0620-30

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