Prescription medicine
Ethinyl estradiol and ethynodiol Brand names: Valtya, Zovia, Kelnor; first approved as Demulen 1/50-21
Ethinyl estradiol and ethynodiol (Zovia) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.379 per zovia 1-35 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and ethynodiol FDA label on DailyMed (effective February 5, 2025, Xiromed LLC); the NDA 16927 record on Drugs@FDA; every ethinyl estradiol and ethynodiol label on DailyMed.
Highlights of the record
FDA label of February 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.
Used for
From the label: indications and usageValtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- April 24, 1970 Demulen 1/50-21, Gd Searle Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first December 30, 1991; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.379 per tablet Zovia 1-35 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 159 through July 30, 2026
What is ethinyl estradiol and ethynodiol used for?
From the label: indications and usageValtya 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. […]
Conditions named in the indications of ethinyl estradiol and ethynodiol's FDA labels, with every medicine labeled for each:
From other ethinyl estradiol and ethynodiol labelsBirth control: INDICATIONS AND USAGE Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Source: FDA drug label (VALTYA 1/50), Xiromed LLC, effective February 5, 2025 (SPL set 1aff28b0-93eb-5e44-9164-d76ffd08cd59), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and ethynodiol (Zovia)?
The FDA approved the first generic ethinyl estradiol and ethynodiol on December 30, 1991. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ethinyl estradiol and ethynodiol from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1991 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethinyl estradiol and ethynodiol (Zovia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.379 per Zovia 1-35 tablet, up 10% from $0.345 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zovia 1-35 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Kelnor 1-35 28 tablet | Generic | $0.379 per tablet | $11.37 | +10% |
| Valtya 1 mg-35 mcg tablet | Generic | $0.379 per tablet | $11.37 | n/a |
| Valtya 1 mg-50 mcg tablet | Generic | $0.738 per tablet | $22.15 | +2% |
| Zovia 1-35 tablet | Generic | $0.379 per tablet | $11.37 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ethinyl estradiol and ethynodiol label say about other medicines?
The ethinyl estradiol and ethynodiol label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ritonavir | contraindications | … Known or suspected pregnancy Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT). |
Check ethinyl estradiol and ethynodiol against other medicines
Source: FDA drug label (VALTYA 1/50), Xiromed LLC, effective February 5, 2025 (SPL set 1aff28b0-93eb-5e44-9164-d76ffd08cd59), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and ethynodiol?
The FDA Adverse Event Reporting System holds 159 reports that list ethinyl estradiol and ethynodiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 14 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ethinyl estradiol and ethynodiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other