Kurvelo levonorgestrel and ethinyl estradiol Kit — NDC 50090-6374-0 (Billing 50090-6374-00)
This is a package of Kurvelo levonorgestrel and ethinyl estradiol Kit from A-S Medication Solutions, marketed since Feb 2021 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 50090-6374-0 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 50090 labeler · 6374 product · 0 package
- Package marketed since
- Feb 20, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5009063740 3
- 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
- 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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 5, 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2332 | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 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 |
|---|---|---|---|---|
| 50090-6374-00 You're viewing this Main listing | 1 KIT in 1 CARTON * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK | 2023-02-20 | — | 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 | — |
| 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 | — |
| Marlissa 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 | — |
| Levora 51862-0097-06 | Mayne | 1 kit | $0.145 | AB | Discontinued | — |
| Levonorgestrel And Ethinyl Estradiol 00378-7287-53 | Mylan | 3 pouches | $0.151 | AB1 | Availability likely | — |
| Lutera 51862-0028-06 | Mayne | 1 kit | $0.152 | AB1 | Discontinued | — |
| Lessina 00555-9014-67 | Teva | 3 pouches | $0.154 | — | Availability likely | — |
| Aubra EQ 50102-0220-23 | Afaxys | 3 pouches | $0.154 | AB1 | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0854-73 | Lupin | 1 kit | $0.154 | AB1 | Availability likely | — |
| Aviane 00555-9045-58 | Teva | 6 pouches | $0.154 | — | Availability likely | — |
| Vienva 70700-0118-85 | Xiromed, | 1 kit | $0.154 | AB1 | Availability likely | — |
| Falmina 16714-0359-01 | Northstar | 1 packet | $0.154 | AB1 | Availability likely | — |
| Sronyx 51862-0545-06 | Mayne | 1 kit | $0.174 | AB2 | Discontinued | — |
| Introvale 70700-0117-87 | Xiromed, | 1 kit | $0.184 | AB | FDA listed | — |
| Afirmelle 65862-0849-88 | Aurobindo | 3 pouches | $0.225 | AB1 | FDA listed | — |
| Iclevia 65862-0865-83 | Aurobindo | 3 pouches | $0.227 | AB | FDA listed | — |
| Setlakin 16714-0366-03 | Northstar | 3 pouches | $0.227 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0843-13 | Lupin | 1 kit | $0.227 | AB | Availability likely | — |
| levonorgestrel and ethinyl estradiol 68462-0672-95 | Glenmark | 3 pouches | $0.227 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 | Lupin | 2 pouches | $0.239 | AB | Availability likely | — |
| Levonest 16714-0340-01 | Northstar | 1 packet | $0.324 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0857-73 | Lupin | 1 kit | $0.324 | AB | Availability likely | — |
| Tyblume 00642-7471-01 | Exeltis | 1 kit | $0.828 | — | Availability likely | — |
| levonorgestrel and ethinyl estradiol 42192-0623-03 | Acella | 1 kit | $3.445 | AB3 | Availability likely | — |
| Levonest 50090-2505-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Kurvelothis 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 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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 5, 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 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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 A-S Medication Solutions labeler code 50090
- Estradiol 2 mg Tablet NDC 50090-6363-0
- Biofreeze Professional MENTHOL, UNSPECIFIED FORM 50 mg/mL Gel NDC 50090-6367-0
- Spironolactone 25 mg Tablet, Coated NDC 50090-6369-0
- Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL; 5 mg/mL Solution/ Drops NDC 50090-6371-0
- Hydrochlorothiazide 12.5 mg Tablet NDC 50090-6372-0
- Ipratropium Bromide .5 mg/2.5mL Solution NDC 50090-6373-0
- prednisone 50 mg Tablet NDC 50090-6376-0
- Levalbuterol .63 mg/3mL Solution NDC 50090-6377-0
- Levetiracetam 1000 mg Tablet, Film Coated NDC 50090-6378-0
- Sertraline Hydrochloride 50 mg Tablet, Film Coated NDC 50090-6379-0
- Celecoxib 100 mg Capsule NDC 50090-6380-0
- Amoxicillin and Clavulanate Potassium 400 mg/5mL; 57 mg/5mL Powder, For Suspension NDC 50090-6381-0
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 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 Kurvelo, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 1.How to Start and Take Kurvelo Kurvelo is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED ). Kurvelo 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 Kurvelo Starting Kurvelo 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 Kurvelo: • 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 Kurvelo after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Kurvelo may be started immediately.
An additional method of contraception is not needed if Kurvelo is started immediately. If Kurvelo 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 Kurvelo. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.
Start Kurvelo 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 Kurvelo (see CONTRAINDICATIONS , WARNINGS (1) , PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING ) . Starting Kurvelo after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
Start contraceptive therapy with Kurvelo following the instructions in Table 3 for women not currently using hormonal contraception. Kurvelo 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 Kurvelo (see CONTRAINDICATIONS , WARNINGS (9) , PRECAUTIONS (6) and FDA APPROVED PATIENT LABELING) .
2.Dosing Kurvelo Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Kurvelo as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.
3.Missed doses Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling. Table 4: Instructions for Missed Kurvelo Tablets • If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. • If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets th… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Kurvelo 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: Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1) ]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ] .
Have cerebrovascular disease [see WARNINGS (1) ] . Have coronary artery disease [see WARNINGS (1) ] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ] .
Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ] . Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ] . 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) ] .
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 Kurvelo if an arterial or venous thrombotic/thromboembolic event occurs. Stop Kurvelo if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. Discontinue Kurvelo during prolonged immobilization.
If feasible, stop Kurvelo at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. Start Kurvelo no earlier than four weeks after delivery in females who are not breast-feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.
Before starting Kurvelo evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. Kurvelo 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. Kurvelo 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 2.Liver Disease Elevated Liver Enzymes Kurvelo is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS ). Discontinue Kurvelo 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 Kurvelo is contraindicated in females with benign or malignant liver tumors (see CONTRAINDICATIONS ). COCs increase the risk of hepatic adenomas.
An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death from abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users.
The attributable risk of liver cancers in COC users is less than one case per million users. 3.Hypertension Kur… [Excerpted — this section continues on DailyMed.]
🆘 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 Kurvelo Tablets (levonorgestrel and ethinyl estradiol tablets USP) (3 x 28) are available in packages of 3 blisters, each containing 28 tablets as follows: Each blister strip contains 21 light orange tablets, each containing of 0.15 mg levonorgestrel and 30 mcg ethinyl estradiol, debossed with "LU" on one side and "U31" on the other side. 7 inert pink, round, biconvex tablets, debossed with "LU" on one side and "U32" on the other side. They are supplied as follows: Kurvelo tablets are available in a blister (NDC 68180-844-71) containing 28 tablets, such 3 blisters are packed in a carton (NDC 68180-844-73).
Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: June 2022
📋 Description ▾
DESCRIPTION Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Levonorgestrel is chemically ( d (-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one). Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol).
Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Levonorgestrel Ethinyl Estradiol
💬 Patient Medication Information ▾
Patient Information Kurvelo ™ (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg) What is the most important information I should know about Kurvelo? Do not use Kurvelo 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 Kurvelo? Kurvelo is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does Kurvelo 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 Kurvelo. 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 Kurvelo?
Do not take Kurvelo 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 Kurvelo, stop taking Kurvelo right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Kurvelo.
What should I tell my healthcare provider before taking Kurvelo? 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. Kurvelo may decrease the amount of breast milk you make.
A small amount of the hormones in Kurvelo 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.
Kurvelo may affect the way other medicines work, and other medicines may affect how well Kurvelo works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Kurvelo? Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of Kurvelo?
Like pregnancy, Kurvelo may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age.
Serious blood clots are more likely to happen when you: first start taking birth contr… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS 1.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 [see WARNINGS ( 7 )]. In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
2.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. 3.Gastrointestinal Motility Diarrhea and/or vomiting may reduce hormone absorption (see DOSAGE AND ADMINISTRATION) .
4.Drug Interactions The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations . No drug-drug interaction studies were conducted with Kurvelo. 4.1Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 1 includes substances that demonstrated an important drug interaction with Kurvelo.
Table 1: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers Clinical effect • Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. • Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding. Prevention or management • Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. • Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability.
Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. John's wort may vary widely based on preparation. , and certain protease inhibitors (see separate section on protease inhibitors below).
Colesevelam Clinical effect • Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. • Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC. Prevention or management Administer 4 or more hours apart to attenuate this drug interaction. Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent.
Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs. Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant decreas… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
KURVELO (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT Label Image
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |