Levora
NDC Package 53002-1565-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1565 and is authorized under FDA application ANDA073594.

Identification & Billing

NDC Package Code
53002-1565-3
Package Description
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
Product Code
53002-1565
11-Digit Billing Format
53002156503
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
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. 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 UseNA - not availableLevonorgestrel 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 spongeNulliparous women920Parous women2040Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, jellies, and vaginal suppositories)626Periodic abstinence (all methods)1-9 Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.25Withdrawal419No contraception (planned pregnancy)8585

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA073594
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2016
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53002-1565). Click a package code to view its specific billing and regulatory data.

53002-1565-1
1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
53002-1565-6
6 BLISTER PACK in 1 PACKAGE / 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 53002-1565-3 identifies a specific commercial package of 3 blister pack in 1 package / 1 kit in 1 blister pack of Levora, labeled by Rpk Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 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 Rpk Pharmaceuticals, Inc. on August 03, 2016. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002156503. 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 (5-4-1)
53002-1565-3
11-Digit CMS (5-4-2)
53002-1565-03

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