MARLISSA Levonorgestrel and Ethinyl Estradiol Kit — NDC 68462-388-29 (Billing 68462-0388-29)
This is a package of MARLISSA Levonorgestrel and Ethinyl Estradiol Kit from Glenmark Pharmaceuticals Inc., USA, marketed since Feb 2012 and currently FDA-listed; retail pharmacies pay about $0.1135 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 68462-388-29 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68462 labeler · 388 product · 29 package
- Package marketed since
- Feb 29, 2012
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0368462388297
- Medicaid fills, this package
- 13,030 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): 003314
- GCN: 11530
- GPI-14 (Medi-Span): 25990002400310
- HICL (First Databank): 001460
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 238019
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
- It prevents pregnancy. It is a combined hormonal birth control with an estrogen and a progestin. It comes as daily tablets or as the weekly Twirla patch.
- With tablets, you take one at the same time every day, no more than 24 hours apart. With the Twirla patch, you wear one patch for a week, three weeks in a row, then take a patch-fr...
- Headache, nausea, acne, breast tenderness, mood changes, and irregular bleeding are the common ones. Bleeding changes often settle with time. Call your doctor if they persist.
- Get help for chest pain, sudden shortness of breath, leg swelling or pain, vision loss, or severe new headaches. These can signal a blood clot or stroke. Also report yellowing of y...
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 | $0.114 | $0.34 / 3 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.2377 | $0.71 / 3 kit |
| Medicare drug plans payPart D · Q2 2026 | $0.2200 | $0.66 / 3 kit |
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 |
|---|---|---|---|---|
| 68462-0388-29 You're viewing this Main listing | 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2012-02-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levonorgestrel And Ethinyl Estradiol 00378-6550-53 | Mylan | 3 pouches | $0.113 | AB | Discontinued | save 1% |
| Altavera 70700-0116-85 | Xiromed, | 1 kit | $0.114 | AB | Availability likely | — |
| Ayuna 65862-0848-88 | Aurobindo | 3 pouches | $0.114 | AB | Availability likely | — |
| Chateal EQ 50102-0230-23 | Afaxys | 3 pouches | $0.114 | AB | Availability likely | — |
| Marlissathis 68462-0388-29 | Glenmark | 1 kit | $0.114 | AB | Availability likely | — |
| Kurvelo 68180-0844-73 | Lupin | 63 tablets | $0.114 | AB | Availability likely | — |
| Portia 00555-9020-58 | Teva | 6 pouches | $0.114 | — | Availability likely | — |
| Daysee 68180-0846-13 | Lupin | 2 pouches | $0.125 | AB | Availability likely | +10% |
| Levora 51862-0097-06 | Mayne | 1 kit | $0.145 | AB | Discontinued | +27% |
| Levonorgestrel And Ethinyl Estradiol 00378-7287-53 | Mylan | 3 pouches | $0.151 | AB1 | Availability likely | +33% |
| Lutera 51862-0028-06 | Mayne | 1 kit | $0.152 | AB1 | Discontinued | +34% |
| Lessina 00555-9014-67 | Teva | 3 pouches | $0.154 | — | Availability likely | +35% |
| Aubra EQ 50102-0220-23 | Afaxys | 3 pouches | $0.154 | AB1 | Availability likely | +35% |
| Levonorgestrel and Ethinyl Estradiol 68180-0854-73 | Lupin | 1 kit | $0.154 | AB1 | Availability likely | +35% |
| Aviane 00555-9045-58 | Teva | 6 pouches | $0.154 | — | Availability likely | +35% |
| Vienva 70700-0118-85 | Xiromed, | 1 kit | $0.154 | AB1 | Availability likely | +35% |
| Falmina 16714-0359-01 | Northstar | 1 packet | $0.154 | AB1 | Availability likely | +35% |
| Sronyx 51862-0545-06 | Mayne | 1 kit | $0.174 | AB2 | Discontinued | +53% |
| Introvale 70700-0117-87 | Xiromed, | 1 kit | $0.184 | AB | FDA listed | +62% |
| Afirmelle 65862-0849-88 | Aurobindo | 3 pouches | $0.225 | AB1 | FDA listed | +98% |
| Iclevia 65862-0865-83 | Aurobindo | 3 pouches | $0.227 | AB | FDA listed | +100% |
| Setlakin 16714-0366-03 | Northstar | 3 pouches | $0.227 | AB | Availability likely | +100% |
| Levonorgestrel and Ethinyl Estradiol 68180-0843-13 | Lupin | 1 kit | $0.227 | AB | Availability likely | +100% |
| levonorgestrel and ethinyl estradiol 68462-0672-95 | Glenmark | 3 pouches | $0.227 | AB | Availability likely | +100% |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 | Lupin | 2 pouches | $0.239 | AB | Availability likely | +111% |
| Levonest 16714-0340-01 | Northstar | 1 packet | $0.324 | AB | Availability likely | +185% |
| Levonorgestrel and Ethinyl Estradiol 68180-0857-73 | Lupin | 1 kit | $0.324 | AB | Availability likely | +185% |
| Tyblume 00642-7471-01 | Exeltis | 1 kit | $0.828 | — | Availability likely | +629% |
| levonorgestrel and ethinyl estradiol 42192-0623-03 | Acella | 1 kit | $3.445 | AB3 | Availability likely | +2935% |
| Levonest 50090-2505-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Kurvelo 50090-6374-00 | A-S | 21 tablets | — | AB | FDA listed | — |
| Altavera 63629-2343-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Lutera 55741-0005-06 | Dr. | 1 kit | — | AB1 | FDA listed | — |
| Balcoltra 75854-0602-02 | Avion | 1 kit | — | AB3 | FDA listed | — |
| Vienva Tm 50090-5580-00 | A-S | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0003-07 | Naari | 1 kit | — | AB | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4898-08 | Apotex | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4899-08 | Apotex | 1 kit | — | AB | FDA listed | — |
| Vienva TM 63629-2344-01 | Bryant | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0004-07 | Naari | 1 kit | — | AB1 | FDA listed | — |
| Aviane 63187-0889-28 | Proficient | 1 pouch | — | — | 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
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.
🧪 Avoiding an ingredient? See Ethinyl Estradiol / Levonorgestrel inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
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 Glenmark Pharmaceuticals Inc., USA labeler code 68462
- Eszopiclone 1 mg Tablet, Film Coated NDC 68462-382-01
- Eszopiclone 2 mg Tablet, Film Coated NDC 68462-383-01
- Eszopiclone 3 mg Tablet, Film Coated NDC 68462-384-01
- Mometasone Furoate 1 mg/mL Lotion NDC 68462-385-02
- solifenacin succinate 5 mg Tablet, Film Coated NDC 68462-386-14
- solifenacin succinate 10 mg Tablet, Film Coated, Extended Release NDC 68462-387-14
- Esomeprazole Magnesium 20 mg Capsule, Delayed Release Pellets NDC 68462-390-10
- Esomeprazole Magnesium 40 mg Capsule, Delayed Release Pellets NDC 68462-391-10
- raloxifene hydrochloride 60 mg Tablet, Film Coated NDC 68462-393-01
- ALYACEN 1/35 norethindrone and ethinyl estradiol Kit NDC 68462-394-29
- Omeprazole 10 mg Capsule, Delayed Release NDC 68462-395-01
- Omeprazole 20 mg Capsule, Delayed Release NDC 68462-396-01
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 MARLISSA ® , are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
🎯 Indications and Usage ▾
INDICATIONS AND USAGE MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 1. How to Start and Take MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED ). MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may be started using either a Day 1 start or a Sunday start (see Table 3).
For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 3: Instructions for Administration of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) in females with no current use of hormonal contraception Day 1 start • Take first tablet without regard to meals on the first day of menses • Take subsequent tablets once daily at the same time each day • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Sunday start • Take first tablet without regard to meals on the first Sunday after the onset of menstrual period • Take subsequent tablets once daily at the same time each day • Use additional nonhormonal contraception for the first seven days of product use • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Switching from another contraceptive method • A COC Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets): • On the day when the new pack of the previous COC would have been started • Transdermal patch • On the day when next application would have been scheduled • Vaginal ring • On the day when next insertion would have been scheduled • Injection • On the day when next injection would have been scheduled • Intrauterine contraceptive • On the day of removal • Implant • On the day of removal Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may be started immediately.
An additional method of contraception is not needed if MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is started immediately. • If MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets). Second-trimester • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.
Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS , WARNINGS (1), PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING ) . Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) after Childbirth • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
Start contraceptive therapy with MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for women not currently using hormonal contraception. • MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is not recommended for use in lactating women (see PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING ). • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS , WARNINGS (9), PRECAUTIONS (6) and FDA‑ APPROVED P… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females who are known to have the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1)]. o Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1)]. o Have cerebrovascular disease [see WARNINGS (1)]. o Have coronary artery disease [see WARNINGS (1)]. o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1)]. o Have inherited or acquired hypercoagulopathies [ see WARNING S (1)]. o Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3)]. o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7)]. o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8)]. • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive. • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see WARNINGS (2)]. • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS (5)]. • Undiagnosed abnormal uterine bleeding [see WARNINGS (9)].
⚠️ Warnings ▾
WARNINGS 1. Thromboembolic Disorders and Other Vascular Conditions • Stop MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if an arterial or venous thrombotic/thromboembolic event occurs. • Stop MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. • Discontinue MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) during prolonged immobilization.
If feasible, stop MARLISSA ® at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. • Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) no earlier than four weeks after delivery in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. • Before starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.
MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases (see CONTRAINDICATIONS ). Arterial Events COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.
MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS ). Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Venous Events Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS ). While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1).
The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well.
The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.
Figure 1: Likelihood of Developing a VTE Figure1.jpg 2. Liver Disease Elevated Liver Enzymes MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS ). Discontinue MARLISSA ® if jaundice develops.
Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded. Liver Tumors MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular adverse events [see BOXED WARNING and WARNINGS (1)] • Vascular events [see WARNINGS (1)] • Liver disease [see WARNINGS (2)] • Hypertension [see WARNINGS (3)] • Gallbladder disease [see WARNINGS (6)] • Carbohydrate and lipid effects [see WARNINGS (7)] • Headache [see WARNINGS (8)] • Carcinoma of the cervix [see WARNINGS (11)] Adverse reactions reported by COC users and described elsewhere in the labeling are: • Bleeding irregularities and amenorrhea [see WARNINGS (9)] • Mood changes, including depression [see WARNINGS (10)] • Melasma/chloasma which may persist [see WARNINGS (14)] • Edema/fluid retention [see PRECAUTIONS (2)] • Diminution in lactation when given immediately postpartum [see PRECAUTIONS (7)] 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).
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 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. The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.
Figure-2
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED/ STORAGE AND HANDLING MARLISSA ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg) is available in cartons (NDC 68462-388- 29) of 3 blisters (NDC 68462-388-84), each containing 28 tablets. Each blister contains: 21 Active Tablets: Light orange to orange color, round, biconvex, film coated tablets with ‘A5’ debossed on one side. 7 Inert Tablets: Light pink to pink color, round, biconvex, uncoated tablets with ‘A6’ debossed on one side.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?
1 (888) 721-7115 www.glenmarkpharma-us.com April 2025 logo2
📋 Description ▾
DESCRIPTION MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 MW: 312.4 Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol.
Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. StructureLevonorgestrel.jpg StructureEE.jpg
📄 Patient Package Insert ▾
Patient Information MARLISSA ® (MĀR-LIS-SĂ) (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) What is the most important information I should know about MARLISSA ® (levonorgestrel and ethinyl estradiol tablets)? Do not use MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke.
This risk increases with age and the number of cigarettes you smoke. What is MARLISSA ® (levonorgestrel and ethinyl estradiol tablets)? MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) work for contraception? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use MARLISSA ® (levonorgestrel and ethinyl estradiol tablets). The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness.
The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Who should not take MARLISSA ® (levonorgestrel and ethinyl estradiol tablets)?
Do not take MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if you: • smoke and are over 35 years of age • had blood clots in your arms, legs, lungs, or eyes • had a problem with your blood that makes it clot more than normal • have certain heart valve problems or irregular heart beat • had a stroke • had a heart attack • have high blood pressure that cannot be controlled by medicine • have diabetes with kidney, eye, nerve, or blood vessel damage • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age • had breast cancer or any cancer that is sensitive to female hormones • have liver problems, including liver tumors • have any unexplained vaginal bleeding • are pregnant • take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. If any of these conditions happen while you are taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), stop taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets).
What should I tell my healthcare provider before taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets)? Tell your healthcare provider if you: • are pregnant or think you may be pregnant • are depressed now or have been depressed in the past • had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) • are breastfeeding or plan to breastfeed. MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may decrease the amount of breast milk you make.
A small amount of the hormones in MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
MARLISSA ® (levonorgestrel and ethinyl estradi… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions For Use MARLISSA ® (MĀR-LIS-SĂ) (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) Important Information about taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) • Take 1 pill every day at the same time. Take the pills in the order directed on your pill pack. • Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant .
The more pills you miss, the more likely you are to get pregnant. • If you have trouble remembering to take MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), talk to your healthcare provider. • When you first start taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. • You may feel sick to your stomach (nauseous), especially during the first few months of taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets).
If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider. • Missing pills can also cause spotting or light bleeding, even when you take the missed pills later.
On the days you take 2 pills to make up for missed pills (see What should I do if I miss any MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) pills? below), you could also feel a little sick to your stomach. • It is not uncommon to miss a period. However, if you miss a period and have not taken MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets). • If you have vomiting or diarrhea within 3-4 hours of taking a light orange pill, take another light orange pill as soon as possible.
Continue taking all your remaining pills in order. Start the first pill of your next pill pack the day after finishing your current pill pack. This will be 1 day earlier than originally scheduled.
Continue on your new schedule. • If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider. • Stop taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.
Before you start taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets): • Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your pill pack. • Look at your pill pack. Your pill pack consists of 1 blister that holds 28 individually sealed pills.
The 28 pills consist of 21 light orange to orange pills (3 rows of 7 pills) and 7 light pink to pink pills (1 row of 7 pills). See Figure A . • Also find: o Where on the blister to start taking pills (upper left corner) and o In what order to take the pills (follow the weeks) • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills. When should I start taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets)?
If you start taking MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) and you have not used a hormonal birth control method before: • There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control p… [Excerpted — this section continues on DailyMed.]
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