Volnea Kit
NDC Package 70700-122-85

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Volnea (desogestrel and ethinyl estradiol) kits is 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. This formulation utilizes a kit delivery system. Marketed by Xiromed, Llc., this product is identified by NDC 70700-122 and is authorized under FDA application ANDA202689.

Identification & Billing

NDC Package Code
70700-122-85
Package Description
3 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON (70700-122-84) / 1 KIT in 1 BLISTER PACK
Product Code
70700-122
11-Digit Billing Format
70700012285
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: 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
Non-Proprietary Name
Desogestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
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 rates.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 YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.Method (1)Typical UseAmong 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.(2)Perfect UseAmong 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.(3)(4)ChanceThe 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.8585SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2 Post-Ovulation1Withdrawal194CapWith spermicidal cream or jelly. Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragm20656CondomWithout spermicides. 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.

Regulatory & Marketing

Labeler Name
Xiromed, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202689
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 70700-122-85 identifies a specific commercial package of 3 carton in 1 carton / 1 blister pack in 1 carton (70700-122-84) / 1 kit in 1 blister pack of Volnea, a human prescription drug labeled by Xiromed, Llc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Xiromed, Llc. on December 01, 2017. The current certification is valid through December 31, 2026.

How is this Xiromed, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700012285. 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 (5-3-2)
70700-122-85
11-Digit CMS (5-4-2)
70700-0122-85

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