Volnea Desogestrel and Ethinyl Estradiol Kit — NDC 70700-122-85 (Billing 70700-0122-85)
This is a package of Volnea Desogestrel and Ethinyl Estradiol Kit from Xiromed, LLC., marketed since Dec 2017 and currently FDA-listed; retail pharmacies pay about $0.1725 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70700-122-85 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70700 labeler · 122 product · 85 package
- Package marketed since
- Feb 22, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7070012285 3
- Medicaid fills, this package
- 18,453 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 040125
- GCN: 94868
- GPI-14 (Medi-Span): 25991002050320
- HICL (First Databank): 018520
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 248310
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Estrogen class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.173 | $0.52 / 3 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.3574 | $1.07 / 3 kit |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70700-0122-85 You're viewing this Main listing | 3 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2018-02-22 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Reclipsen 28 Day 00093-3304-16 | Teva | 6 pouches | $0.135 | AB | Availability likely | save 22% |
| Apri 28 Day 00555-9043-58 | Teva | 6 pouches | $0.135 | AB | Availability likely | save 22% |
| Isibloom 70700-0113-85 | Xiromed, | 1 kit | $0.135 | AB | Availability likely | save 22% |
| Enskyce 68180-0739-73 | Lupin | 21 tablets | $0.135 | AB | Availability likely | save 22% |
| Cyred EQ 50102-0254-23 | Afaxys | 3 pouches | $0.135 | AB | Availability likely | save 22% |
| Juleber 16714-0464-01 | Northstar | 1 packet | $0.135 | AB | Availability likely | save 22% |
| Desogestrel and Ethinyl Estradiol 51862-0514-01 | Mayne | 1 packet | $0.163 | AB | FDA listed | save 6% |
| Enskyce 68180-0891-73 | Lupin | 3 pouches | $0.163 | AB | Discontinued | save 6% |
| Volneathis 70700-0122-85 | Xiromed, | 1 kit | $0.172 | AB | Availability likely | — |
| Velivet Triphasic Regimen 00555-9051-67 | Teva | 3 pouches | $0.536 | AB | Availability likely | +211% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Xiromed, LLC. labeler code 70700
- ALTAVERA Levonorgestrel and Ethinyl Estradiol Kit NDC 70700-116-85
- Introvale Levonorgestrel and Ethinyl Estradiol Kit NDC 70700-117-87
- Vienva Levonorgestrel and Ethinyl Estradiol Kit NDC 70700-118-85
- Estarylla Norgestimate and ethinyl estradiol Kit NDC 70700-119-85
- Tri-Lo- Estarylla norgestimate and ethinyl estradiol Kit NDC 70700-120-85
- Tri-Estarylla norgestimate and ethinyl estradiol Kit NDC 70700-121-85
- JAIMIESS levonorgestrel / ethinyl estradiol and Kit NDC 70700-123-87
- LoJaimiess levonorgestrel/ethinyl estradiol and ethinyl Kit NDC 70700-124-87
- Betamethasone Valerate 1.2 mg/g Aerosol, Foam NDC 70700-141-19
- Estradiol .25 mg/.25g Gel NDC 70700-143-35
- Estradiol .5 mg/.5g Gel NDC 70700-144-35
- Estradiol 1 mg/g Gel NDC 70700-145-35
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 Volnea, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rate. TABLE 2 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 a Method (1) Typical Use b (2) Perfect Use c (3) (4) Chance d 85 85 Spermicides e 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal f 2 Post-Ovulation 1 Withdrawal 19 4 Cap g Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm g 20 6 56 Condom h Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only
0.5 Combined
0.1IUD Progesterone T 2 1.5 81 Copper T 380A 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 Adapted from Hatcher et al., 1998, Ref#1. a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) 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. c) 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. d) 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. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly. h) Without spermicides.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets must be taken exactly as directed and at intervals not exceeding 24 hours Volnea ™ may be initiated using either a Sunday start or a Day 1 start. NOTE: Each blister card 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 blister card 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 Volnea should be considered. The use of Volnea 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 Volnea postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a 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 tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 green (inert) tablet daily for 2 days and 1 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 yellow tablet. [If switching from a Sunday Start oral contraceptive, the first Volnea (desogestrel/ethinyl estradiol and ethinyl estradiol) 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 tablet, she should take the missed tablet as soon as she remembers.
If the patient misses 2 consecutive 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 tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 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 tablet daily for 21 days, one green (inert) tablet daily for 2 days followed by 1 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 yellow tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 cons… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Volnea is contrainindicated in females who are known to have or develop 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 genetital 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 con… [Excerpted — this section continues on DailyMed.]
🤒 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 - 1.12 (Figure 2) (64-68).
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 - 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: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraception 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
🆘 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 epidemiologic 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 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. Pharmacokinetics Absorption Desogestrel is rapidly and almost completely absorbed and converted into etonogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of desogestrel compared to a solution, as measured by serum levels of etonogestrel, is approximately 100%.
Desogestrel/ethinyl estradiol and ethinyl estradiol tablets provide two different regimens of ethinyl estradiol; 0.02 mg in the combination tablet [white] as well as 0.01 mg in the yellow tablet. Ethinyl estradiol is rapidly and almost completely absorbed. After a single dose of desogestrel/ethinyl estradiol and ethinyl estradiol combination tablet [white], the relative bioavailability of ethinyl estradiol is approximately 93% while the relative bioavailability of the 0.01 mg tablet [yellow] is 99%.
The effect of food on the bioavailability of desogestrel/ethinyl estradiol and ethinyl estradiol tablets following oral administration has not been evaluated. The pharmacokinetics of etonogestrel and ethinyl estradiol following multiple dose administration of desogestrel/ethinyl estradiol and ethinyl estradiol tablets were determined during the third cycle in 17 subjects. Plasma concentrations of etonogestrel and ethinyl estradiol reached steady-state by Day 21.
The AUC(0–24) for etonogestrel at steady-state on Day 21 was approximately 2.2 times higher than AUC(0–24) on Day 1 of the third cycle. The pharmacokinetic parameters of etonogestrel and ethinyl estradiol during the third cycle following multiple dose administration of desogestrel/ethinyl estradiol and ethinyl estradiol tablets are summarized in Table 1. TABLE 1: MEAN (SD) PHARMACOKINETIC PARAMETERS OF DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL OVER A 28-DAY DOSING PERIOD IN THE THIRD CYCLE (n=17).
Etonogestrel Day Dose a) mg C max pg/mL T max h t 1/2 h AUC 0–24 pg/mL•hr CL/F L/h 1 0.15 2503.6 (987.6) 2.4 (1) 29.8 (16.3) 17,832 (5674) 5.4 (2.5) 21 0.15 4091.2 (1186.2) 1.6 (0.7) 27.8 (7.2) 39,391 (12,134) 4.4 (1.4) a) Desogestrel Ethinyl Estradio l Day Dose mg C max pg/mL T max h t 1/2 h AUC 0–24 pg/mL•hr CL/F L/h 1 0.02 51.9 (15.4) 2.9 (1.2) 16.5 (4.8) 566 (173) a) 25.7 (9.1) 21 0.02 62.2 (25.9) 2 (0.8) 23.9 (25.5) 597 (127) a) 35.1 (8.2) 24 0.01 24.6 (10.8) 2.4 (1) 18.8 (10.3) 246 (65) 43.6 (12.2) 28 0.01 35.3 (27.5) 2.1 (1.3) 18.9 (8.3) 312 (62) 33.2 (6.6) C max – measured peak concentration T max – observed time of peak concentration t 1/2 – elimination half-life, calculated by 0.693/K elim AUC 0–24 – area under the concentration-time curve calculated by the linear trapezoidal rule (Time 0 to 24 hours) CL/F – apparent clearance a) n=16 Distribution Etonogestrel, the active metabolite of desogestrel, was found to be 99% protein bound, primarily to sex hormone-binding globulin (SHBG).
Ethinyl estradiol is approximately 98.3% bound, mainly to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Desogestrel, in combination with ethinyl estradiol, does not counteract the estrogen-induced increase in SHBG, resulting in lower serum levels of free testosterone (96-99).
Metabolism Desogestrel Desogestrel is rapidly and completely metabolized by hydroxylation in the intestinal mucosa and on first pass through the liver to etonogestrel. Other metabolites (i.e., 3α-OH-desogestrel, 3β-OH-desogestrel, and 3α-OH-… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Volnea (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) contains 21 round white tablets, 2 round green tablets and 5 round yellow tablets. NDC 70700-122-85, Carton containing 3 blister cards. Each white tablet (debossed with “ SZ ” on one side and “ D1 ” on the other side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol.
Each yellow tablet (debossed with “ SZ ” on one side and “ L1 ” on the other side) contains 0.01 mg ethinyl estradiol. Each green tablet (debossed with “ SZ ” on one side and “ J1 ” on the other side) contains inert ingredients. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Volnea (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include alpha-tocopherol, colloidal silicon dioxide, aquarius cool vanilla (contains hypromellose 2910, polyethylene glycol and titanium dioxide), corn starch, lactose monohydrate, povidone, and stearic acid, followed by 2 inert green round tablets contain the following inactive ingredients: aquarius cottage green (contains FD&C blue no.
2 aluminum lake, hypromellose 2910, polysorbate 80, titanium dioxide, triacetin, and yellow iron oxide), colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and povidone. Volnea also contains 5 yellow round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include lactose monohydrate, microcrystalline cellulose, magnesium stearate, and opadry yellow (contains lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, and yellow iron oxide).
The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows: structure formula
⚠️ Precautions ▾
PRECAUTIONS 1. General Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections. 2.
Physical examination and follow up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests.
In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3.
Lipid disorders Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. 4.
Liver function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. 5.
Fluid retention Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. 6.
Contact lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 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 desogestrel and ethinyl estradiol and ethinyl estradiol tablets , with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations (see CONTRAINDICATIONS and WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ). Co-administration of desogestrel and ethinyl estradiol and ethinyl estradiol tablets 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. 8. Interactions with laboratory tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
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. Other binding proteins may be elevated in serum.
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. High-density lipoprotein choleste… [Excerpted — this section continues on DailyMed.]
📚 References ▾
REFERENCES 1. Hatcher RA, Trussell J, Stewart F et al. Contraceptive Technology: Seventeenth Revised Edition, New York: Irvington Publishers, 1998, in press.
2. Stadel BV. Oral contraceptives and cardiovascular disease.
(Pt. 1). N Engl J Med 1981; 305:612–618.
3. Stadel BV. Oral contraceptives and cardiovascular disease.
(Pt. 2). N Engl J Med 1981; 305:672–677.
4. Adam SA, Thorogood M. Oral contraception and myocardial infarction revisited: the effects of new preparations and prescribing patterns.
Br J Obstet and Gynecol 1981; 88:838–845. 5. Mann JI, Inman WH.
Oral contraceptives and death from myocardial infarction. Br Med J 1975; 2(5965):245–248. 6.
Mann JI, Vessey MP, Thorogood M, Doll R. Myocardial infarction in young women with special reference to oral contraceptive practice. Br Med J 1975; 2(5956):241–245.
7. Royal College of General Practitioners’ Oral Contraception Study: Further analyses of mortality in oral contraceptive users. Lancet 1981; 1:541–546.
8. Slone D, Shapiro S, Kaufman DW, Rosenberg L, Miettinen OS, Stolley PD. Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives.
N Engl J Med 1981; 305:420–424. 9. Vessey MP.
Female hormones and vascular disease—an epidemiological overview. Br J Fam Plann 1980; 6:1–12. 10.
Russell-Briefel RG, Ezzati TM, Fulwood R, Perlman JA, Murphy RS. Cardiovascular risk status and oral contraceptive use, United States, 1976–80. Prevent Med 1986; 15:352–362.
11. Goldbaum GM, Kendrick JS, Hogelin GC, Gentry EM. The relative impact of smoking and oral contraceptive use on women in the United States.
JAMA 1987; 258:1339–1342. 12. Layde PM, Beral V.
Further analyses of mortality in oral contraceptive users: Royal College General Practitioners’ Oral Contraception Study. (Table 5) Lancet 1981; 1:541–546. 13.
Knopp RH. Arteriosclerosis risk: the roles of oral contraceptives and postmenopausal estrogens. J Reprod Med 1986; 31(9) (Supplement):913–921.
14. Krauss RM, Roy S, Mishell DR, Casagrande J, Pike MC. Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses.
Am J Obstet 1983; 145:446–452. 15. Wahl P, Walden C, Knopp R, Hoover J, Wallace R, Heiss G, Rifkind B.
Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N Engl J Med 1983; 308:862–867. 16.
Wynn V, Niththyananthan R. The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins. Am J Obstet Gynecol 1982; 142:766–771.
17. Wynn V, Godsland I. Effects of oral contraceptives and carbohydrate metabolism.
J Reprod Med 1986; 31 (9) (Supplement):892–897. 18. LaRosa JC.
Atherosclerotic risk factors in cardiovascular disease. J Reprod Med 1986; 31 (9) (Supplement):906–912. 19.
Inman WH, Vessey MP. Investigation of death from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. Br Med J 1968; 2 (5599):193–199.
20. Maguire MG, Tonascia J, Sartwell PE, Stolley PD, Tockman MS. Increased risk of thrombosis due to oral contraceptives: a further report.
Am J Epidemiol 1979; 110 (2):188–195. 21. Pettiti DB, Wingerd J, Pellegrin F, Ramacharan S.
Risk of vascular disease in women: smoking, oral contraceptives, noncontraceptive estrogens, and other factors. JAMA 1979; 242:1150–1154. 22.
Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease. Br Med J 1968; 2 (5599):199–205.
23. Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease.
A further report. Br Med J 1969; 2 (5658):651–657. 24.
Porter JB, Hunter JR, Danielson DA, Jick H, Stergachis A. Oral contraceptives and non-fatal vascular disease—recent experience. Obstet Gynecol 1982; 59 (3):299–302.
25. Vessey M, Doll R, Peto R, Johnson B, Wiggins P. A long-term follow-up study of women using different methods of contraception: an interim report.
Biosocial Sci 197… [Excerpted — this section continues on DailyMed.]
📄 Patient Package Insert ▾
PATIENT PACKAGE INSERT BRIEF SUMMARY Volnea ® ( desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 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 are strongly advised not to smoke.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections. Oral contraceptives, also known as “birth control pills” or “the pill”, are taken to prevent pregnancy, and when taken correctly, have a failure rate of about 1% per year when used without missing any pills.
The typical failure rate of large numbers of pill users is less than 5% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.
For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: smoke have high blood pressure, diabetes, high cholesterol have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast, jaundice, or malignant or benign liver tumors.
Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious.
The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, headache, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young.
However, you should know that the following medical conditions have been associated with or made worse by the pill: Blood clots in the legs (thrombophlebitis) or lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes, and subsequent serious medical consequences. Liver tumors, which may rupture and cause severe bleeding.
A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
High blood pressure, although blood pressure usually returns to normal when the pill is stopped. The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill.
In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness. There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives.
However, this finding may be related to factors other than the use of oral contracep… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
INSTRUCTIONS TO PATIENTS HOW TO TAKE THE PILL IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING YOUR PILLS: BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME.
If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TOTHEIR STOMACH DURING THE FIRST 1 TO 3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away.
If it doesn’t go away, check with your doctor or healthcare provider. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOMEMEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor orhealthcare provider. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider about how to make pill-taking easier or about using another method of birth control.
IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or healthcare provider. BEFORE YOU START TAKING YOUR PILLS DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.
LOOK AT YOUR PILL PACK: IT WILL HAVE 28 PILLS: This 28-pill pack has 26 “active” [white and yellow] pills (with hormones) and 2 “inactive” [green] pills (without hormones). ALSO FIND: 1) where on the pack to start taking the pills,2) in what order to take the pills (follow the arrows) and 3) the week numbers as shown in the picture below. 4.
BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or sponge) to use as a back-up in case you miss pills. AN EXTRA, FULL PILL PACK. WHEN TO START THE FIRST PACK OF PILLS You have a choice of which day to start taking your first pack of pills.
Decide with your doctor or healthcare provider which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START 1.
Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). 2. Place this day label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted.
Note: If the first day of your period is a Sunday, you can skip step #1 and #2. 3. Take the first "active" [white] pill of the first pack during the first 24 hours of your period .
4.You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period. SUNDAY START Take the first “active” [white] pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms, foam, or the sponge are good back-up methods of birth control. WHAT TO DO DURING THE MONTH 1.
TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2.
WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS: 21 pills : Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21-day packs.
28 pills : Start the next pack on the day after you… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 70700-122-85 Volnea ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01mg Rx only
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
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About this NDC listing & data coverage
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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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
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| 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) | ✓ Available |