Prescription medicine
Desogestrel and ethinyl estradiol Brand names: Apri, Cyred, Isibloom, Azurette, Volnea; first approved as Desogen
Desogestrel and ethinyl estradiol (Apri) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.172 per azurette 28 day tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the desogestrel and ethinyl estradiol FDA label on DailyMed (effective December 12, 2025, Lupin Pharmaceuticals, Inc.); the NDA 20071 record on Drugs@FDA; every desogestrel and ethinyl estradiol label on DailyMed.
Highlights of the record
FDA label of December 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Enskyce™ (desogestrel and ethinyl estradiol tablets USP), should not be used by women who are over 35 years of age and smoke. Do not use Enskyce if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Do not use Enskyce if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. Some women should not use the pill. […]
Used for
From the label: indications and usageEnskyce Tablets are 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
- December 10, 1992 Desogen, Organon Usa Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first August 12, 1999; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.172 per tablet Azurette 28 day tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2014 0 Class I among all firms' recalls; latest September 3, 2025
- FAERS reports
- 4,024 through July 30, 2026
What is desogestrel and ethinyl estradiol used for?
From the label: indications and usageEnskyce Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Enskyce, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. […]
Conditions named in the indications of desogestrel and ethinyl estradiol's FDA labels, with every medicine labeled for each:
From other desogestrel and ethinyl estradiol labelsBirth control: INDICATIONS AND USAGE Enskyce Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Source: FDA drug label (ENSKYCE), Lupin Pharmaceuticals, Inc., effective December 12, 2025 (SPL set 799fa1d8-4e7b-4b5e-844d-d638896a4b02), via openFDA; the full label on DailyMed
Is there a generic for desogestrel and ethinyl estradiol (Apri)?
The FDA approved the first generic desogestrel and ethinyl estradiol on August 12, 1999. 24 generic applications are approved; 20 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 desogestrel and ethinyl estradiol from 15 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.
- 1992 earliest approval on file
- 1999 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for desogestrel and ethinyl estradiol (Apri)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.172 per Azurette 28 day tablet, down 13% from $0.198 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.
- Azurette 28 day tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Apri 28 day tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Azurette 28 day tablet | Generic | $0.172 per tablet | $5.17 | -13% |
| Cyred eq 28 day tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Enskyce 28 tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Isibloom 28 day tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Juleber 28 day tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Kariva 28 day tablet | Generic | $0.172 per tablet | $5.17 | -13% |
| Pimtrea 28 day tablet | Generic | $0.172 per tablet | $5.17 | -13% |
| Reclipsen 28 day tablet | Generic | $0.135 per tablet | $4.06 | -11% |
| Velivet 28 day tablet | Generic | $0.536 per tablet | $16.09 | -18% |
| Viorele 28 day tablet | Generic | $0.172 per tablet | $5.17 | -13% |
| Volnea 0.15-0.02-0.01 mg tablet | Generic | $0.172 per tablet | $5.17 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has desogestrel and ethinyl estradiol been recalled?
The FDA's Enforcement Report lists 4 recalls naming desogestrel and ethinyl estradiol since 2014: 0 Class I (the most serious), 1 Class II, 3 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 3, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Impurities/Degradation Specifications |
| June 17, 2014 | Class III | Teva Pharmaceuticals USA | Failed Impurities/Degradation Specifications: out of specification impurity test results. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the desogestrel and ethinyl estradiol label say about other medicines?
The desogestrel and ethinyl estradiol 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 | boxed warning | … tumor (benign or cancerous) If you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. |
Check desogestrel and ethinyl estradiol against other medicines
Source: FDA drug label (ENSKYCE), Lupin Pharmaceuticals, Inc., effective December 12, 2025 (SPL set 799fa1d8-4e7b-4b5e-844d-d638896a4b02), via openFDA; the full label on DailyMed
What do FAERS reports show for desogestrel and ethinyl estradiol?
The FDA Adverse Event Reporting System holds 4,024 reports that list desogestrel and ethinyl estradiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 568 are coded as a death and 1,233 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 next?
- Desogestrel and ethinyl estradiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other