Volnea
NDC Package 53002-1813-3

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.

Volnea is (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets 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 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1813 and is authorized under FDA application ANDA202689.

Identification & Billing

NDC Package Code
53002-1813-3
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
53002-1813
11-Digit Billing Format
53002181303
RxNorm Crosswalk
  • RxCUI: 2001756 - {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Volnea 28 Day]
  • RxCUI: 2001756 - Volnea 28 Day Pack
  • RxCUI: 248310 - ethinyl estradiol 0.01 MG Oral Tablet
  • RxCUI: 248310 - ethinyl estradiol 10 MCG Oral Tablet
  • RxCUI: 249357 - desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet

Clinical Specifications

Proprietary Name
Volnea
Dosage Form
-
Usage Information
Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets 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 2 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rate.TABLE 2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use atOne YearaMethod(1)Typical Useb(2)Perfect Usec(3)(4)Chanced8585Spermicidese26640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-Thermalf2 Post-Ovulation1Withdrawal194Capg Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragmg20656Condomh Female (Reality)21556 Male14361Pill571 Progestin Only0.5 Combined0.1IUD Progesterone T21.581 Copper T 380A0.80.678 LNg 200.10.181Depo-Provera0.30.370Norplant and Norplant-20.050.0588Female sterilization0.50.5100Male sterilization0.150.10100Adapted from Hatcher et al., 1998, Ref#1.a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.b) 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.c) 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.d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.e) Foams, creams, gels, vaginal suppositories, and vaginal film.f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.g) With spermicidal cream or jelly.h) Without spermicides.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA202689
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2017
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 (53002-1813). Click a package code to view its specific billing and regulatory data.

53002-1813-1
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
53002-1813-6
6 BLISTER PACK in 1 CARTON / 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 53002-1813-3 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Volnea, labeled by Rpk Pharmaceuticals, Inc.. 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 December 01, 2017. 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: 53002181303. 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)
53002-1813-3
11-Digit CMS (5-4-2)
53002-1813-03

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