Lutera levonorgestrel and ethinyl estradiol Kit — NDC 55741-005-06 (Billing 55741-0005-06)
This is a package of Lutera levonorgestrel and ethinyl estradiol Kit from Dr. Reddys Laboratories Inc., marketed since Feb 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 55741-005-06 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 55741 labeler · 005 product · 06 package
- Package marketed since
- Feb 13, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5574100506 8
- 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): 030986
- GCN: 11534
- HICL (First Databank): 001460
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 242297
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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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 |
|---|---|---|---|---|
| 55741-0005-06 You're viewing this Main listing | 6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2026-02-13 | — | Active |
| 55741-0005-28 55741-005-28 | 1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK | 2026-02-13 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Lutera levonorgestrel and ethinyl estradiol Kit?
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 | — |
| Kurvelo 50090-6374-00 | A-S | 21 tablets | — | AB | FDA listed | — |
| Altavera 63629-2343-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Luterathis 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
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 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 Dr. Reddys Laboratories Inc. labeler code 55741
- Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon 4 mg Gum, Chewing NDC 55741-001-10
- Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon 2 mg Gum, Chewing NDC 55741-004-10
- Doans Extra Strength Magnesium salicylate 580 mg Tablet NDC 55741-224-24
- Habitrol Step 3 Nicotine Transdermal System Patch 7 mg/24h Patch, Extended Release NDC 55741-446-70
- Habitrol Step 2 Nicotine Transdermal System Patch 14 mg/24h Patch, Extended Release NDC 55741-447-70
- Habitrol Step 1 Nicotine Transdermal System Patch 21 mg/24h Patch, Extended Release NDC 55741-448-28
- nicotine transdermal system Kit NDC 55741-449-56
- Doans Maximum Strength Magnesium salicylate 580 mg Tablet NDC 55741-600-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Lutera is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Lutera in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported.
This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles.
Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m 2 . Females with a BMI greater than 30 kg/m 2 accounted for 12.1% (n=179) of the study population.
Females with a BMI over 35 kg/m 2 accounted for 4.3% (n=63) of the study population.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Lutera ® (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lutera is one orange tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Lutera tablets be taken at the same time each day.
During The First Cycle Of Use The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking Lutera on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start). Sunday start: The patient is instructed to begin taking Lutera on the first Sunday after the onset of menstruation.
If menstruation begins on a Sunday, the first tablet (orange) is taken that day. One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started.
During the first cycle, contraceptive reliance should not be placed on Lutera until an orange tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days. Day 1 start: During the first cycle of medication, the patient is instructed to begin taking Lutera during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days.
Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Lutera tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Lutera tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days.
After the first cycle of use The patient begins her next and all subsequent courses of tablets on the day after taking her last white tablet. She should follow the same dosing schedule: 21 days on orange tablets followed by 7 days on white tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken an orange tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Lutera. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen.
When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Lutera on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Lutera the next day.
If switching from an implant or injection, the patient should start Lutera on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, implant, or intrauterine system (IUS), the patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days of the first pack. If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occur, the patient is instructed to c… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease (current or past history) Valvular heart disease with thrombogenic complications Thrombogenic rhythm disorders Hereditary or acquired thrombophilias Prolonged immobilization (especially with major surgery) Diabetes with vascular involvement Headaches with focal neurological symptoms or migraine with aura Women with migraine who are 35 years or older Uncontrolled hypertension Known or suspected carcinoma of the breast or personal history of breast cancer Known or suspected estrogen-or progesterone sensitive malignancy Undiagnosed abnormal vaginal bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas, or active liver disease Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
⚠️ Warnings ▾
WARNINGS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (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 Lutera, are contraindicated in women who are over 35 years of age and smoke.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc, at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.
Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. FIGURE 2: 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 associated with the use of oral CHCs were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site conditions: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Pyschiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins figure2
🆘 Overdosage ▾
OVERDOSAGE Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mode of Action Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of Lutera (Levonorgestrel and Ethinyl Estradiol Tablets, USP) in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism.
Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%. After a single dose of levonorgestrel and ethinyl estradiol tablets to 22 women under fasting conditions, maximum serum concentrations of levonorgestrel are 2.8 ± 0.9 ng/mL (mean ± SD) at 1.6 ± 0.9 hours. At steady state, attained from day 19 onwards, maximum levonorgestrel concentrations of 6.0 ± 2.7 ng/mL are reached at 1.5 ± 0.5 hours after the daily dose.
The minimum serum levels of levonorgestrel at steady state are 1.9 ± 1.0 ng/mL. Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively (Figure 1). Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively.
The kinetics of total levonorgestrel are non-linear due to an increase in binding of levonorgestrel to sex hormone binding globulin (SHBG), which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol. Following a single dose, maximum serum concentrations of ethinyl estradiol of 62 ± 21 pg/mL are reached at 1.5 ± 0.5 hours. At steady state, attained from at least day 6 onwards, maximum concentrations of ethinyl estradiol were 77 ± 30 pg/mL and were reached at 1.3 ± 0.7 hours after the daily dose.
The minimum serum levels of ethinyl estradiol at steady state are 10.5 ± 5.1 pg/mL. Ethinyl estradiol concentrations did not increase from days 1 to 6, but did increase by 19% from days 1 to 21 (Figure 1). FIGURE 1 Mean (SE) levonorgestrel and ethinyl estradiol serum concentrations in 22 subjects receiving 100 mcg levonorgestrel and 20 mcg ethinyl estradiol TABLE 1 provides a summary of levonorgestrel and ethinyl estradiol pharmacokinetic parameters. table1 figure1 Distribution Levonorgestrel in serum is primarily bound to SHBG.
Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Metabolism Levonorgestrel: The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation.
Most of the metabolites that circulate in the blood are sulfates of 3α, 5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides. Some of the parent levonorgestrel also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.
Ethinyl estradiol: Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2-hydroxylation that is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. Levels of Cytochrome P450 (CYP3A) vary widely among individuals and can explain the variation in rates of ethinyl estradiol 2-hydroxylation.
Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation. Excretion The elimination half-life for levonorgestrel is approximately 36 ± 13 hours at steady state. Levonorgestrel and its metabolites are primarily excreted in the urine (40% to 68%) and about 16% to 48% are excreted in feces.
The elimination half-lif… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lutera ® (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.1 mg/0.02 mg) is available in a compact blister card (NDC 55741-005-28), containing 28 tablets arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: 21 active tablets: orange, round tablet debossed with "A3" on one side. 7 inert tablets: white, round tablet debossed with "P" on one side and " N " on the other side. Lutera ® Tablets are available in the following configuations Carton of 6 NDC 55741-005-06 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP controlled room temperature].
Distributed by: Dr. Reddy’s Laboratories Inc. Princeton, NJ 08540 Product of China I 0221 Rev.
A Rev. 11/2025 Brief Summary Patient Package Insert This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
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 approximately 1.0% per year (1 pregnancy per 100 women per year of use) when used without missing any pills. The average failure rate of large numbers of pill users is approximately 5% per year (5 pregnancies per 100 women per year of use) 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 or death.
The risks associated with taking oral contraceptives increase significantly if you: smoke. have high blood pressure, diabetes, high cholesterol, or a tendency to form blood clots. have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, malignant or benign liver tumors, or major surgery with prolonged immobilization. have headaches with neurological symptoms. You should not take the pill if you 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. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Although cardiovascular disease risks may be increased with oral-contraceptive use after age 40 in healthy, nonsmoking women, there are also greater potential health risks associated with pregnancy in older women.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (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 Lutera, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
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, 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 do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill: 1. Blood clots in the legs (thrombophlebitis) and lungs (pulmonary embolism), blockage or rupture of a blood vessel in the brain (s… [Excerpted — this section continues on DailyMed.]
📋 Description ▾
DESCRIPTION 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch. structure
⚠️ Precautions ▾
PRECAUTIONS 1. General Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. This product contains FD&C Yellow No.
5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
2. Physical Examination and Follow-Up A periodic personal and family medical history and complete physical examination are appropriate for all women, 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, pelvic organs, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate diagnostic 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.
(See WARNINGS ) A small proportion of women will have adverse lipid changes while taking oral contraceptives. Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users.
Elevations of plasma triglycerides may lead to pancreatitis and other complications. 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. Depression Monitor females with a history of depression and discontinue Lutera if depression recurs to a serious degree.
Data on the association of CHCs with onset of depression or exacerbation of existing depression are limited. 7. Contact Lenses Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. Gastrointestinal Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations. If a patient vomits or has diarrhea after taking an active tablet, instruct the patient to not take an additional active tablet on that day and to continue the regimen the next day as prescribed.
In case of vomiting or diarrhea that continues for 48 hours or greater, instruct the patient to contact the health care provider and use back-up or alternative contraception until active tablets have been taken for 7 consecutive days after vomiting and diarrhea have resolved. 9. Drug Interactions Concomitant Use with HCV Combination Therapy-Liver Enzyme Elevation Do not co-administer Lutera with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
Changes in Contraceptive Effectiveness Associated with Coadministration of Other Products: Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of con… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of Lutera (Levonorgestrel and Ethinyl Estradiol Tablets, USP) in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%.
After a single dose of levonorgestrel and ethinyl estradiol tablets to 22 women under fasting conditions, maximum serum concentrations of levonorgestrel are 2.8 ± 0.9 ng/mL (mean ± SD) at 1.6 ± 0.9 hours. At steady state, attained from day 19 onwards, maximum levonorgestrel concentrations of 6.0 ± 2.7 ng/mL are reached at 1.5 ± 0.5 hours after the daily dose. The minimum serum levels of levonorgestrel at steady state are 1.9 ± 1.0 ng/mL.
Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively (Figure 1). Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively. The kinetics of total levonorgestrel are non-linear due to an increase in binding of levonorgestrel to sex hormone binding globulin (SHBG), which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol.
Following a single dose, maximum serum concentrations of ethinyl estradiol of 62 ± 21 pg/mL are reached at 1.5 ± 0.5 hours. At steady state, attained from at least day 6 onwards, maximum concentrations of ethinyl estradiol were 77 ± 30 pg/mL and were reached at 1.3 ± 0.7 hours after the daily dose. The minimum serum levels of ethinyl estradiol at steady state are 10.5 ± 5.1 pg/mL.
Ethinyl estradiol concentrations did not increase from days 1 to 6, but did increase by 19% from days 1 to 21 (Figure 1). FIGURE 1 Mean (SE) levonorgestrel and ethinyl estradiol serum concentrations in 22 subjects receiving 100 mcg levonorgestrel and 20 mcg ethinyl estradiol TABLE 1 provides a summary of levonorgestrel and ethinyl estradiol pharmacokinetic parameters. table1 figure1 Distribution Levonorgestrel in serum is primarily bound to SHBG. Ethinyl estradiol is about 97% bound to plasma albumin.
Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Metabolism Levonorgestrel: The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation. Most of the metabolites that circulate in the blood are sulfates of 3α, 5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides.
Some of the parent levonorgestrel also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users. Ethinyl estradiol: Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2-hydroxylation that is the major oxidative reaction.
The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. Levels of Cytochrome P450 (CYP3A) vary widely among individuals and can explain the variation in rates of ethinyl estradiol 2-hydroxylation. Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation.
Excretion The elimination half-life for levonorgestrel is approximately 36 ± 13 hours at steady state. Levonorgestrel and its metabolites are primarily excreted in the urine (40% to 68%) and about 16% to 48% are excreted in feces. The elimination half-life of ethinyl estradiol is 18 ± 4.7 hours at steady state.
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