NDC Package 53002-1565-1 Levora

Levonorgestrel And Ethinyl Estradiol Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

53002-1565-1

Package Description:

1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

Product Code:

53002-1565

Proprietary Name:

Levora

Non-Proprietary Name:

Levonorgestrel And Ethinyl Estradiol

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

11-Digit NDC Billing Format:

53002156501

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Rpk Pharmaceuticals, Inc.

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

ANDA073594

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

08-03-2016

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

53002 - Rpk Pharmaceuticals, Inc.
- 53002-1565 - Levora
  - 53002-1565-1 - 1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
53002-1565-3	3 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 disclaimer below.

Frequently Asked Questions

What is NDC 53002-1565-1?

The NDC Packaged Code 53002-1565-1 is assigned to a package of 1 blister pack in 1 package / 1 kit in 1 blister pack of Levora, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via form.

Is NDC 53002-1565 included in the NDC Directory?

Yes, Levora with product code 53002-1565 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on August 03, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53002-1565-1?

The 11-digit format is 53002156501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	53002-1565-1	5-4-2	53002-1565-01

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