Levonest Kit
NDC Package 16714-340-04

11-digit billing NDC: 16714034004 · Billing unit: EA · 6 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Levonest (levonorgestrel and ethinyl estradiol) kits is oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. This formulation utilizes a kit delivery system. Marketed by Northstar Rx Llc, this product is identified by NDC 16714-340 and is authorized under FDA application ANDA090719.

Identification & Billing

NDC Package Code
16714-340-04
Package Description
6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
16714-340
11-Digit Billing Format
16714034004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk
  • RxCUI: 1095227 - {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Levonest 28 Day]
  • RxCUI: 1095227 - LEVONEST 28 Day Triphasic Pack
  • RxCUI: 1095227 - Levonest 28 Day Pack
  • RxCUI: 310230 - ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet
  • RxCUI: 348804 - ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet

Clinical Specifications

Proprietary Name
Levonest
Non-Proprietary Name
Levonorgestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHODMethodPerfect UseTypical UseLevonorgestrel implants0.050.05Male sterilization0.10.15Female sterilization0.50.5Depo-Provera®(injectable progestogen)0.30.3Oral contraceptives5Combined0.1NAProgestin only0.5NAIUDProgesterone1.52.0Copper T 380A0.60.8Condom (male) without spermicide314(Female) without spermicide521Cervical capNulliparous women920Parous women2640Vaginal spongeNulliparous women920Parous women2040Diaphragm withspermicidal cream or jelly620Spermicides alone(foam, creams, jellies, and vaginal suppositories)626Periodic abstinence (all methods)1-9*25Withdrawal419No contraception (planned pregnancy)8585NA – not available*Depending on method (calendar, ovulation, symptothermal, post-ovulation)Adapted from Hatcher RA et al, Contraceptive Technology: 17thRevised Edition. NY, NY: Ardent Media, Inc., 1998

Regulatory & Marketing

Labeler Name
Northstar Rx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090719
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2010
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16714-340). Click a package code to view its specific billing and regulatory data.

16714-340-01
1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
16714-340-02
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
16714-340-03
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 16714-340-04 identifies a specific commercial package of 6 blister pack in 1 carton / 1 kit in 1 blister pack of Levonest, a human prescription drug labeled by Northstar Rx Llc. This kit is formulated for use and contains 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 Northstar Rx Llc on December 29, 2010. The current certification is valid through December 31, 2026.

How is this Northstar Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16714034004. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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)
16714-340-04
11-Digit CMS (5-4-2)
16714-0340-04

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