Levonorgestrel And Ethinyl Estradiol Kit
NDC Package 0378-6550-53

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

Package Information

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 Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-6550 and is authorized under FDA application ANDA091663.

Identification & Billing

NDC Package Code
0378-6550-53
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK
Product Code
0378-6550
11-Digit Billing Format
00378655053
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk
  • RxCUI: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 238019 - ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748878 - {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Levonorgestrel And Ethinyl Estradiol
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 contraceptives5           Combined0.1NA           Progestin only0.5NAIUD           Progesterone1.52.0           Copper T 380A0.60.8Condom (male) without spermicide314           (Female) without spermicide521Cervical cap           Nulliparous women920           Parous women2640Vaginal sponge           Nulliparous women920           Parous women2040Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, jellies, and vaginal     suppositories)626Periodic abstinence (all methods)1 to 9a25Withdrawal419No contraception (planned pregnancy)8585NA- not available a Depending on method (calendar, ovulation, symptothermal, post-ovulation)Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.NY, NY: Ardent Media, Inc., 1998.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091663
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-16-2013
End Marketing Date
06-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-6550-53 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-6550-85) / 1 kit in 1 blister pack of Levonorgestrel And Ethinyl Estradiol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. 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 Mylan Pharmaceuticals Inc. on August 16, 2013.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378655053. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
0378-6550-53
11-Digit CMS (5-4-2)
00378-6550-53

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