VIORELE Desogestrel and Ethinyl Estradiol Kit, 1 kit
Other active recalls for Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Estrogen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and desogestrel (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3483 | $0.35 / 1 kit |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Simliya 65862-0886-88 | Aurobindo | 3 pouches | $0.160 | AB | FDA listed | — |
| Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol 00378-7296-53 | Mylan | 3 pouches | $0.161 | AB | Availability likely | — |
| Viorele 68462-0318-29 | Glenmark | 1 kit | $0.161 | AB | Availability likely | — |
| Viorelethis 50090-1395-00 | A-S | 1 kit | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol and ethinyl estradiol 79929-0020-07 | Naari | 1 pouch | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol and ethinyl estradiol 60505-4895-02 | Apotex | 1 pouch | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50090-1395-00 You're viewing this | 1 KIT in 1 KIT (50090-1395-0) | 2014-11-28 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: 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, including VIORELE, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. VIORELE ® may be initiated using either a Sunday start or a Day 1 start. NOTE: Each cycle pack blister is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen.
Six different “day label strips” are provided with each cycle pack blister in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of VIORELE ® should be considered.
The use of VIORELE ® for contraception may be initiated 4 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for Nursing mothers).
If the patient starts on VIORELE ® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white to off-white tablet has been taken daily for 7 days. SUNDAY START When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. Using a Sunday start, tablets are taken daily without interruption as follows: The first white to off-white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white to off-white tablet is taken on that day).
One white to off-white tablet is taken daily for 21 days, followed by 1 pale green to yellowish green (inert) tablet daily for 2 days and 1 light yellow to yellow (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last light yellow to yellow tablet. [If switching from a Sunday start oral contraceptive, the first VIORELE ® tablet should be taken on the second Sunday after the last tablet of a 21-day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.] If a patient misses 1 white to off-white tablet, she should take the missed tablet as soon as she remembers.
If the patient misses 2 consecutive white to off-white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white to off-white tablets in the third week or misses 3 or more white to off-white tablets in a row at any time during the cycle, the patient should keep taking 1 white to off-white tablet daily until the next Sunday.
On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. DAY 1 START Counting the first day of menstruation as “Day 1”, tablets are taken without interruption as follows: One white to off-white tablet daily for 21 days, one pale green to yellowish green (inert) tablet daily for 2 days followed by 1 light yellow to yellow (ethinyl estradiol) tablet daily for 5 days.
For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last light yellow to yellow tablet. [If switching directly from another oral contraceptive, the first white to off-white t…
⛔ Contraindications ▾
CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas • 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 ).
⚠️ Warnings ▾
WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies.
Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users.
The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author’s permission). For further information, the reader is referred to a text on epidemiologic methods.
1. Thromboembolic disorders and other vascular problems a. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established.
Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thromboembolic disease, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease (2,3,19-24). Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization (25). The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped (2).
Several epidemiologic studies indicate that third generation oral contraceptives, including those containing desogestrel, are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives (102-104). In general, these studies indicate an approximate two-fold increased risk, which corresponds to an additional 1 to 2 cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this two-fold increase in risk.
A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives (9, 26). The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions (9, 26). If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization.
Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast-feed. b. Myocardial infarction An increased risk of myocardial infarction has been attributed to oral contr…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): • Thrombophlebitis and venous thrombosis with or without embolism • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Hepatic adenomas or benign liver tumors Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 2).
(64 to 68). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). (64, 67, 69) One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. FIGURE 2: RELEVANT STUDIES OF RISK OF BREAST CANCER WITH COMBINED ORAL CONTRACEPTIVES RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
There is evidence of an association between the following conditions and the use of oral contraceptives: • Mesenteric thrombosis • Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: • Nausea • Vomiting • Gastrointestinal symptoms (such as abdominal cramps and bloating) • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Temporary infertility after discontinuation of treatment • Edema • Melasma which may persist • Breast changes: tenderness, enlargement, secretion • Change in weight (increase or decrease) • Change in cervical erosion and secretion • Diminution in lactation when given immediately postpartum • Cholestatic jaundice • Migraine • Rash (allergic) • Mental depression • Reduced tolerance to carbohydrates • Vaginal candidiasis • Change in corneal curvature (steepening) • Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: • Pre-menstrual syndrome • Cataracts • Changes in appetite • Cystitis-like syndrome • Headache • Nervousness • Dizziness • Hirsutism • Loss of scalp hair • Erythema multiforme • Erythema nodosum • Hemorrhagic eruption • Vaginitis • Porphyria • Impaired renal function • Hemolytic uremic syndrome • Acne • Changes in libido • Colitis • Budd-Chiari Syndrome figure2
🔄 Drug Interactions ▾
7. Drug interactions Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines (72).
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy - Liver Enzyme Elevation Co-administration of VIORELE ® with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated, due to potential for ALT elevations (see CONTRAINDICATION S, WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
Co-administration of VIORELE ® and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations. Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
🔄 Drug / Laboratory Test Interactions ▾
8. Interactions with laboratory tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: a. Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. b.
Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered. c. Other binding proteins may be elevated in serum. d.
Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged. e. High-density lipoprotein cholesterol (HDL-C) and triglycerides may be increased, while low-density lipoprotein cholesterol (LDL-C) and total cholesterol (Total-C) may be decreased or unchanged. f. Glucose tolerance may be decreased. g.
Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
🤰 Pregnancy ▾
10. Pregnancy Discontinue VIORELE if pregnancy occurs because there is no reason to use COCs in pregnancy. See WARNINGS section.
🧒 Pediatric Use ▾
12. Pediatric use Safety and efficacy of VIORELE ® has been established in women of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
🆘 Overdosage ▾
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Receptor binding studies, as well as studies in animals, have shown that etonogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity (91, 92).
The relevance of this latter finding in humans is unknown.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) contains 21 round white to off-white tablets, 2 round pale green to yellowish green tablets and 5 round light yellow to yellow tablets in a blister. Each white to off-white, biconvex, film-coated tablet (debossed with ‘C1’ on one side and ‘G’ on the other side) contains 0.15 mg desogestrel, USP and 0.02 mg ethinyl estradiol, USP. Each pale green to yellowish green, biconvex, film-coated tablet (debossed with ‘C3’ on one side and ‘G’ on the other side) contains inert ingredients.
Each light yellow to yellow colored, biconvex, film-coated tablet (debossed with ‘C2’ on one side and ‘G’ on the other side) contains 0.01 mg ethinyl estradiol, USP. VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) are available in cartons (NDC 68462-318-29) of 3 blisters (NDC 68462-318-84) each containing 28 tablets. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white to off-white, round tablets each containing 0.15 mg desogestrel, USP (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include vitamin E, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, stearic acid, lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2 inert pale green to yellowish green, round tablets with following inactive ingredients: lactose, starch, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow, FD&C blue No.
2 indigo carmine aluminum lake. VIORELE ® also contains 5 light yellow to yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which include vitamin E, lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow. The molecular weights for desogestrel, USP and ethinyl estradiol, USP are 310.48 g/mol and 296.40 g/mol respectively.
The structural formulas are as follows: figure
💬 Information for Patients ▾
PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (PATIENT PACKAGE INSERT BRIEF SUMMARY and DETAILED PATIENT PACKAGE INSERT). • Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs (see BOXED WARNING and CONTRAINDICATIONS ). • Counsel patients that the increased risk of venous thromboembolism compared to nonusers of CHCs is greatest after initially starting a CHC or restarting (following a 4-week or greater interruption in intake) the same or a different CHC (see WARNINGS ). • Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted infections. • Counsel patients to take one tablet daily by mouth at the same time every day.
Instruct patients what to do in the event pills are missed (see DOSAGE AND ADMINISTRATION ). • Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs (see PRECAUTIONS ). • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established (see PRECAUTIONS ). • Counsel any patient who starts VIORELE postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a white to off-white tablet for 7 consecutive days (see DOSAGE AND ADMINISTRATION ). • Counsel patients that amenorrhea may occur.
Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness (see WARNINGS ). • Counsel patients with a history of depression that depression may reoccur. Women should contact their healthcare provider if depression occurs (see WARNINGS ).