Levora
NDC Package 54868-4607-0

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.

Levora is 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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4607 and is authorized under FDA application ANDA073594.

Identification & Billing

NDC Package Code
54868-4607-0
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
54868-4607
11-Digit Billing Format
54868460700
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 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
Levora
Dosage Form
-
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.1 The efficacy of these contraceptive methods, except sterilization, 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 A CONTRACEPTIVE FAILURE DURING THE FIRST YEAR OF PERFECT USE AND FIRST YEAR OF TYPICAL USE % of Women Experiencing an Accidental Pregnancy within the First Year of Use Method Typical Usea Perfect Useb a Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. b Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Chance 85 85 Spermicides 21 6 Periodic abstinence 20 1-9 Withdrawal 19 4 Cap    Parous 36 26  Nulliparous 18 9 Sponge    Parous 36 20  Nulliparous 18 9 Diaphragm 18 6 Condom    Female 21 5  Male 12 3 Pill 3   Progestin only  0.5  Combined  0.1 IUD    Progesterone 2 1.5  Copper T 380A 0.8 0.6 Injection (Depo-Provera) 0.3 0.3 Implants (Norplant) 0.09 0.09 Female sterilization 0.4 0.4 Male sterilization 0.15 0.10  Adapted with permission.1  

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA073594
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-10-2002
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 54868-4607-0 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Levora, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on April 10, 2002. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868460700. 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 (5-4-1)
54868-4607-0
11-Digit CMS (5-4-2)
54868-4607-00

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