Valtya 1/50 Kit
NDC Package 70700-305-85

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

Package Information

Valtya 1/50 (ethynodiol diacetate and ethinyl estradiol) kits is valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. This formulation utilizes a kit delivery system. Marketed by Xiromed Llc, this product is identified by NDC 70700-305 and is authorized under FDA application ANDA204704.

Identification & Billing

NDC Package Code
70700-305-85
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (70700-305-84) / 1 KIT in 1 BLISTER PACK
Product Code
70700-305
11-Digit Billing Format
70700030585
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: 2704562 - {21 (ethinyl estradiol 0.05 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Valtya 1/50 28 Day]
  • RxCUI: 2704562 - Valtya 1/50 28 Day Pack
  • RxCUI: 315096 - ethynodiol diacetate 1 MG / ethinyl estradiol 50 MCG Oral Tablet
  • RxCUI: 315096 - ethinyl estradiol 0.05 MG / ethynodiol diacetate 1 MG Oral Tablet
  • RxCUI: 315096 - ethinyl estradiol 50 MCG / ethynodiol diacetate 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Valtya 1/50
Non-Proprietary Name
Ethynodiol Diacetate And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated.Oral contraceptives are highly effective. Table 1 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 progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.Table 1. 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 anunintended pregnancy within the first year of use% of womencontinuing use at one year(C)Method(1)Typical use(A)(2)Perfect use(B)(3)(4)Chance(D)8585Spermicides(E)26640Periodic abstinence2563   Calendar9   Ovulation method3   Sympto-thermal(F)2   Post-ovulation1Withdrawal194Cap(G)   Parous women402642   Nulliparous women20956Sponge   Parous women402042   Nulliparous women20956Diaphragm(G)20656Condom(H)   Female (Reality)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD   Progesterone T21.581   Copper T 380A0.80.678   LNg 200.10.181Injection (Depo-Provera) 0.30.370Implant (Norplant and Norplant-2) 0.050.0588Female sterilization0.50.5100Male sterilization 0.150.1100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.(I)Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.(J)Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.1(A) 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.(B) 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.(C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.(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.(I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).(J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.

Regulatory & Marketing

Labeler Name
Xiromed Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204704
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2025
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 70700-305-85 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (70700-305-84) / 1 kit in 1 blister pack of Valtya 1/50, 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 January 29, 2025. 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: 70700030585. 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)
70700-305-85
11-Digit CMS (5-4-2)
70700-0305-85

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