Juleber Desogestrel and Ethinyl Estradiol Kit, 1 packet
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin 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.
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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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.138 | $0.14 / 1 kit |
| 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 | $0.2400 | $0.24 / 1 kit |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Reclipsen 28 Day 00093-3304-16 | Teva | 6 pouches | $0.138 | AB | Availability likely | — |
| Apri 28 Day 00555-9043-58 | Teva | 6 pouches | $0.138 | AB | Availability likely | — |
| Isibloom 70700-0113-85 | Xiromed, | 1 kit | $0.138 | AB | Availability likely | — |
| Enskyce 68180-0739-73 | Lupin | 21 tablets | $0.138 | AB | Availability likely | — |
| Cyred EQ 50102-0254-23 | Afaxys | 3 pouches | $0.138 | AB | Availability likely | — |
| Juleberthis 16714-0464-01 | Northstar | 1 packet | $0.138 | AB | Availability likely | — |
| Volnea 70700-0122-85 | Xiromed, | 1 kit | $0.161 | AB | Availability likely | +17% |
| Desogestrel and Ethinyl Estradiol 51862-0514-01 | Mayne | 1 packet | $0.163 | AB | FDA listed | +18% |
| Enskyce 68180-0891-73 | Lupin | 3 pouches | $0.163 | AB | Discontinued | +18% |
| Velivet Triphasic Regimen 00555-9051-67 | Teva | 3 pouches | $0.524 | AB | Availability likely | +281% |
| Volnea 63629-2449-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Apri 28 Day 50090-2481-00 | A-S | 1 kit | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol 60505-4896-01 | Apotex | 21 tablets | — | AB | FDA listed | — |
| Averi 75854-0604-01 | Avion | 1 kit | — | — | Discontinued | — |
| Kalliga 65862-0887-88 | Aurobindo | 3 pouches | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol 79929-0006-07 | Naari | 1 kit | — | AB | FDA listed | — |
| Isibloom 63629-2333-01 | Bryant | 1 kit | — | AB | Discontinued | — |
| Desogestrel and Ethinyl Estradiol 31722-0540-33 | Camber | 6 pouches | — | 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.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16714-0464-01 You're viewing this | 1 BLISTER PACK in 1 PACKET (16714-464-01) / 1 KIT in 1 BLISTER PACK | $0.1376 / ea | $0.14 | 2013-07-12 | Active |
| 16714-0464-02 | 1 BLISTER PACK in 1 CARTON (16714-464-02) / 1 KIT in 1 BLISTER PACK | — | — | 2013-07-12 | Active |
| 16714-0464-03 | 3 BLISTER PACK in 1 CARTON (16714-464-03) / 1 KIT in 1 BLISTER PACK | — | — | 2013-07-12 | Active |
| 16714-0464-04 | 6 BLISTER PACK in 1 CARTON (16714-464-04) / 1 KIT in 1 BLISTER PACK | $0.1376 / ea | $0.83 | 2013-07-12 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1376 NADAC).
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 16714-0464-01?
What is the difference between NDC 16714-0464-01 and NDC 16714-0464-02?
What NDC number is used to bill for this package of Juleber Desogestrel and Ethinyl Estradiol Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 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) | ✓ Available |
| 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
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNINGS: 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 JULEBER™, should not be used by women who are over 35 years of age and smoke.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE JULEBER™ is 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 I 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 desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported.
This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. TABLE I: 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 an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfect Use 2 (1) (2) (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Withdrawal 19 4 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Condom 8 Female (Reality) ® 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only
0.5 Combined
0.1IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 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. 1 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.
2 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. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 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. 5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides.
9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA 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 4 yellow…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, JULEBER™ must be taken exactly as directed and at intervals not exceeding 24 hours. JULEBER™ may be initiated using either a Sunday start or a Day 1 start. NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen.
Six different “day label sticker” are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label sticker” that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of JULEBER™ should be considered.
DAY 1 START The dosage of JULEBER TM for the initial cycle of therapy is one orange "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One orange "active" tablet daily for 21 days, then one white "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and an orange "active" tablet is taken the next day.
The use of JULEBER TM for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. 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 Nursing Mothers .) If the patient starts on JULEBER TM postpartum, and has not yet had a period, she should be instructed to use another method of contraception until an orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) orange "active" tablet in Weeks 1, 2, or 3, the orange "active" tablet should be taken as soon as she remembers.
If the patient misses two (2) orange "active" tablets in Week 1 or Week 2, the patient should take two (2) orange "active" tablets the day she remembers and two (2) orange "active" tablets the next day; and then continue taking one (1) orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) orange "active" tablets in the third week or misses three (3) or more orange "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day.
The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. SUNDAY START When taking JULEBER TM , the first orange "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first orange "active" tablet is taken on that day.
If switching directly from another oral contraceptive, the first orange "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One orange "active" tablet daily for 21 days, then one white "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and an orange "active" tablet is taken the next day (Sunday).
When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. The use of JULEBER TM for contraception may be initiated 4 weeks postpartum. 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 thromboe…
⛔ 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 ● Known thrombophilic conditions ● Cerebral vascular or coronary artery disease (current or history) ● Valvular heart disease with complications ● Persistent blood pressure values of ≥160 mm Hg systolic or ≥100 mm Hg diastolic 102 ● Diabetes with vascular involvement ● Headaches with focal neurological symptoms ● Major surgery with prolonged immobilization ● Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive ● Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia ● Undiagnosed abnormal genital bleeding ● Cholestatic jaundice of pregnancy or jaundice with prior pill use ● Acute or chronic hepatocellular disease with abnormal liver function ● Hepatic adenomas or carcinomas ● Known or suspected pregnancy ● Hypersensitivity to any component of this product ● Are receiving Hepatitis C drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see section 5 in WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ).
⚠️ Warnings ▾
WARNINGS 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 JULEBER TM , should not be used by women who are over 35 years of age and smoke.
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, epidemiological 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 nonusers. 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 nonusers.
The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the authors’ permission). For further information, the reader is referred to a text on epidemiological methods.
1. THROMBOEMBOLIC DISORDER 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 nonusers to be 3 for the first episode of superficial venous thrombosis, 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 gradually disappears after combined oral contraceptive (COC) use is stopped.
2 VTE risk is highest in the first year of use and when restarting hormonal contraception after a break of four weeks or longer. 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. In general, these studies indicate an approximate 2-fold increased risk, which corresponds to an additional 1-2 cases of venous thromboembolism per 10,000 women-years of use.
However, data from additional studies have not shown this 2-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 The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions.
26 If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after el…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC. at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2).
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 - 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 8-10 years of COC use.
Figure 2. Risk of Breast Cancer with Combined Oral Contraceptive Use 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. An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS )： ● 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 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 ● Allergic reaction, including rash, urticaria, and angioedema ● 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 a causal 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
🆘 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. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
73–78 Effects on menses: • increased menstrual cycle regularity • decreased blood loss and decreased incidence of iron deficiency anemia • decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: • decreased incidence of functional ovarian cysts • decreased incidence of ectopic pregnancies Effects from long-term use: • decreased incidence of fibroadenomas and fibrocystic disease of the breast • decreased incidence of acute pelvic inflammatory disease • decreased incidence of endometrial cancer • decreased incidence of ovarian cancer
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Combined 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 changes in the endometrium which reduce the likelihood of implantation. Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, 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. Pharmacokinetics Desogestrel is rapidly and almost completely absorbed and converted into 3-ketodesogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of desogestrel, as measured by serum levels of 3-keto-desogestrel, is approximately 84%.
In the third cycle of use after a single dose of desogestrel and ethinyl estradiol tablets, maximum concentrations of 3-keto-desogestrel of 2,805 ± 1,203 pg/mL (mean ± SD) are reached at 1.4 ± 0.8 hours. The area under the curve (AUC 0 -∞) is 33,858 ± 11,043 pg/mL*hr after a single dose. At steady state, attained from at least day 19 onwards, maximum concentrations of 5,840 ± 1,667 pg/mL are reached at 1.4 ± 0.9 hours.
The minimum plasma levels of 3-keto-desogestrel at steady state are 1,400 ± 560 pg/mL. The AUC 0-24 at steady state is 52,299 ± 17,878 pg/mL*hr. The mean AUC 0 -∞ for 3-keto-desogestrel at single dose is significantly lower than the mean AUC 0-24 at steady state.
This indicates that the kinetics of 3-keto-desogestrel are non-linear due to an increase in binding of 3-keto-desogestrel to sex hormone-binding globulin in the cycle, attributed to increased sex hormone-binding globulin levels which are induced by the daily administration of ethinyl estradiol. Sex hormone-binding globulin levels increased significantly in the third treatment cycle from day 1 (150 ± 64 nmol/L) to day 21 (230 ± 59 nmol/L). The elimination half-life for 3-keto-desogestrel is approximately 38 ± 20 hours at steady state.
In addition to 3-keto-desogestrel, other phase I metabolites are 3α -OH-desogestrel, 3β -OH desogestrel, and 3α -OH-5α -H-desogestrel. These other metabolites are not known to have any pharmacologic effects, and are further converted in part by conjugation (phase II metabolism) into polar metabolites, mainly sulfates and glucuronides. Ethinyl estradiol is rapidly and almost completely absorbed.
In the third cycle of use after a single dose of desogestrel and ethinyl estradiol tablets, the relative bioavailability is approximately 83%. In the third cycle of use after a single dose of desogestrel and ethinyl estradiol tablets, maximum concentrations of ethinyl estradiol of 95 ± 34 pg/mL are reached at 1.5 ± 0.8 hours. The AUC 0 -∞ is 1,471 ± 268 pg/mL*hr after a single dose.
At steady state, attained from at least day 19 onwards, maximum ethinyl estradiol concentrations of 141 ± 48 pg/mL are reached at about 1.4 ± 0.7 hours. The minimum serum levels of ethinyl estradiol at steady state are 24 ± 8.3 pg/mL. The AUC 0-24 , at steady state is 1,117 ± 302 pg/mL*hr.
The mean AUC 0 -∞ for ethinyl estradiol following a single dose during treatment cycle 3 does not significantly differ from the mean AUC 0-24 at steady state. This finding indicates linear kinetics for ethinyl estradiol. The elimination half-life is 26 ± 6.8 hours at steady state.
Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol escaping gut wall conjugation undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol.
Sulfate and glucuronide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED JULEBER™ (desogestrel and ethinyl estradiol tablets, USP) contain 21 round orange tablets, and 7 round white tablets in a blister card (NDC 16714-464-01). Each orange tablet (debossed with "S3" on one side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each white tablet (debossed with "P" on one side and " N " on the other side) contains inert ingredients.
JULEBER™ is available in the following configurations: Carton of 1 NDC 16714-464-02 Carton of 3 NDC 16714-464-03 Carton of 6 NDC 16714-464-04 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx Only
📋 Description ▾
DESCRIPTION JULEBER™ (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitaminE, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake.
Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and " N " on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2. image-01
💬 Information for Patients ▾
INFORMATION FOR THE PATIENT See Patient Labeling Printed Below