NDC Package 53002-1566-3 Trivora

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

53002-1566-3

Package Description:

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

Product Code:

53002-1566

Proprietary Name:

Trivora

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 II 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 II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use NA - not available Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998 Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Parous women 26 40 Vaginal sponge Nulliparous women 9 20 Parous women 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1-9Depending on method (calendar, ovulation, symptothermal, post-ovulation) 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85

11-Digit NDC Billing Format:

53002156603

NDC to RxNorm Crosswalk:

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
RxCUI: 348804 - ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet
RxCUI: 348805 - ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet
RxCUI: 348805 - ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet

Labeler Name:

Rpk Pharmaceuticals, Inc.

Sample Package:

FDA Application Number:

ANDA074538

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.
- 53002-1566 - Trivora
  - 53002-1566-3 - 3 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
53002-1566-1	1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
53002-1566-6	6 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 53002-1566-3?

The NDC Packaged Code 53002-1566-3 is assigned to a package of 3 blister pack in 1 package / 1 kit in 1 blister pack of Trivora, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 53002-1566 included in the NDC Directory?

No, Trivora with product code 53002-1566 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. 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 53002-1566-3?

The 11-digit format is 53002156603. 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	53002-1566-3	5-4-2	53002-1566-03

Table of Contents