Prescription medicine
Ethinyl estradiol and norgestrel Brand names: Cryselle, Turqoz, Low-Ogestrel, Elinest; first approved as Ovral
Ethinyl estradiol and norgestrel (Cryselle) is a prescription medicine with an FDA approval on record since 1968. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.302 per cryselle-28 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norgestrel FDA label on DailyMed (effective December 5, 2025, Lupin Pharmaceuticals, Inc.); the NDA 16672 record on Drugs@FDA; every ethinyl estradiol and norgestrel label on DailyMed.
Highlights of the record
FDA label of December 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ].
Used for
From the label: indications and usageTurqoz is indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- April 16, 1968 Ovral, Wyeth Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first July 28, 1999; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.302 per tablet Cryselle-28 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 904 through July 30, 2026
What is ethinyl estradiol and norgestrel used for?
From the label: indications and usageTurqoz is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Conditions named in the indications of ethinyl estradiol and norgestrel's FDA labels, with every medicine labeled for each:
From other ethinyl estradiol and norgestrel labelsBirth control: INDICATIONS AND USAGE Turqoz is indicated for use by females of reproductive potential to prevent pregnancy.
Source: FDA drug label (Turqoz), Lupin Pharmaceuticals, Inc., effective December 5, 2025 (SPL set 5eecfd2c-4bda-4349-b634-199a354fa996), via openFDA; the full label on DailyMed
What does the patient leaflet for ethinyl estradiol and norgestrel say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Turqoz ?Do not use Turqoz if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
From the patient leaflet: How should I store Turqoz ?Store Turqoz at room temperature between 68°F to 77°F (20°C to 25°C). Keep Turqoz and all medicines out of the reach of children. Store away from light.
Source: FDA drug label (Turqoz), Lupin Pharmaceuticals, Inc., effective December 5, 2025 (SPL set 5eecfd2c-4bda-4349-b634-199a354fa996), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and norgestrel (Cryselle)?
The FDA approved the first generic ethinyl estradiol and norgestrel on July 28, 1999. 7 generic applications are approved; 4 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 norgestrel from 7 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.
- 1968 earliest approval on file
- 1999 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 norgestrel (Cryselle)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.302 per Cryselle-28 tablet, down 15% from $0.355 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.
- Cryselle-28 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cryselle-28 tablet | Generic | $0.302 per tablet | $9.06 | -15% |
| Elinest-28 tablet | Generic | $0.302 per tablet | $9.06 | -15% |
| Low-ogestrel-28 tablet | Generic | $0.302 per tablet | $9.06 | -15% |
| Turqoz-28 tablet | Generic | $0.302 per tablet | $9.06 | -15% |
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 norgestrel label say about other medicines?
The ethinyl estradiol and norgestrel 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 | … components of Turqoz Women who 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 norgestrel against other medicines
Source: FDA drug label (Turqoz), Lupin Pharmaceuticals, Inc., effective December 5, 2025 (SPL set 5eecfd2c-4bda-4349-b634-199a354fa996), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and norgestrel?
The FDA Adverse Event Reporting System holds 904 reports that list ethinyl estradiol and norgestrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 139 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ethinyl estradiol and norgestrel?
3 other medicines are given the same way (oral) and in the same FDA class as ethinyl estradiol and norgestrel or labeled mainly for the same use (birth control), the same class first. Birth control lists all 24 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Levonorgestrel | Birth control | 33 labelers | $6.33 per tablet 1.5 mg tablet | No current entry |
| Norethindrone | Birth control | 17 labelers | $0.290 per tablet 5 mg tablet | No current entry |
| Ulipristal | Birth control | none listed | $37.10 per tablet 30 mg tablet | No current entry |
Every medicine labeled for the same conditions as ethinyl estradiol and norgestrel
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ethinyl estradiol and norgestrel
- 3 medicines for the same use
- Ethinyl estradiol and norgestrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other