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Levonorgestrel and Ethinyl Estradiol Kit, 2 pouches — NDC 68180-0848-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Levonorgestrel and Ethinyl Estradiol Kit, 2 pouches — NDC 68180-848-13 (Billing 68180-0848-13)

by Lupin Pharmaceuticals, Inc. · 2 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

This is a package of 2 pouches of Levonorgestrel and Ethinyl Estradiol Kit from Lupin Pharmaceuticals, Inc., marketed since Dec 2011 and currently FDA-listed; retail pharmacies pay about $0.2395 per pouche (NADAC). It is this product's only package size.

NDC 68180-0848-13
🏷️ FDA NDC (as labeled) 68180-848-13 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-848-13
Product NDC 68180-848
11-digit billing NDC 68180084813
NCPDP billing unit EA — each (per item)
RxCUI 242297, 248310, 810096
UPC 0368180848134, 0368180848110
Application # ANDA091674
SPL Set ID 7d82aa5d-aee9-4c72-9b9b-af7adad21f4c
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-12-02
Dosage form KIT
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 25993002300315
GPI class Levonorgest-Eth Estrad 91-Day
GCN Seq No 064935
GCN 18167
HICL code 033792
Ingredient (HICL) L-Norgest/E.estradiol-E.estrad
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name LEVONOR-E ESTRAD 0.1-0.02-0.01
FDB brand name Levonorg-Eth Estrad Eth Estrad
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064935
  • GCN: 18167
  • GPI-14 (Medi-Span): 25993002300315
  • HICL (First Databank): 033792
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 242297
Why two NDCs? The FDA registers this code as 68180-848-13 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68180-0848-13. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Estrogen class.

Pharmacologic class Estrogen
Drug family (ATC) Progestogens and estrogens, sequential preparations, Natural and semisynthetic estrogens, plain, Estrogens
How it works Estrogen Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LEVONOR-E ESTRAD 0.1-0.02-0.01 Ingredient L-Norgest/E.estradiol-E.estrad
📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and levonorgestrel (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Ethinyl Estradiol / Levonorgestrel guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.240 $0.48 / 2 kit
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4451 $0.89 / 2 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Aug 2022 Dec 2025 Aug 2026 $0.411 $0.191
▼ Down 26% over the last 23 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68180-0848-13 You're viewing this Main listing 2 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2011-12-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued save 53%
Altavera 70700-0116-85 Xiromed, 1 kit $0.114 AB Availability likely save 53%
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.114 AB Availability likely save 53%
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.114 AB Availability likely save 53%
Marlissa 68462-0388-29 Glenmark 1 kit $0.114 AB Availability likely save 53%
Kurvelo 68180-0844-73 Lupin 63 tablets $0.114 AB Availability likely save 53%
Portia 00555-9020-58 Teva 6 pouches $0.114 — Availability likely save 53%
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely save 48%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued save 40%
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely save 37%
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued save 37%
Lessina 00555-9014-67 Teva 3 pouches $0.154 — Availability likely save 36%
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.154 AB1 Availability likely save 36%
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.154 AB1 Availability likely save 36%
Aviane 00555-9045-58 Teva 6 pouches $0.154 — Availability likely save 36%
Vienva 70700-0118-85 Xiromed, 1 kit $0.154 AB1 Availability likely save 36%
Falmina 16714-0359-01 Northstar 1 packet $0.154 AB1 Availability likely save 36%
Sronyx 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued save 27%
Introvale 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed save 23%
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed save 6%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed save 5%
Setlakin 16714-0366-03 Northstar 3 pouches $0.227 AB Availability likely save 5%
Levonorgestrel and Ethinyl Estradiol 68180-0843-13 Lupin 1 kit $0.227 AB Availability likely save 5%
levonorgestrel and ethinyl estradiol 68462-0672-95 Glenmark 3 pouches $0.227 AB Availability likely save 5%
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiolthis 68180-0848-13 Lupin 2 pouches $0.239 AB Availability likely —
Levonest 16714-0340-01 Northstar 1 packet $0.324 AB Availability likely +35%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.324 AB Availability likely +35%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 — Availability likely +246%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.445 AB3 Availability likely +1339%
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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Orange / Yellow
ShapeRound
ImprintLU;V22
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LIMITED
FDA applicationANDA091674 (ANDA)
Labeler code68180
First marketedDec 2011
Product typeHuman Prescription Drug
Portfolio404 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🍼 Nursing Mothers 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 201 words ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet is contraindicated in women over 35 years old who smoke. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke. [ See Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]

WARNING TO WOMEN WHO SMOKE Do not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

🎯 Indications and Usage 59 words ▾

1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 )

2.1How to Start and Take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first orange tablet that day. For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days.

Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days. Then take one mustard tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a mustard tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.

Switching to levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant) Start on the Sunday after the patient's next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days. Starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets after Abortion or Miscarriage First-trimester Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may be started on the Sunday after an abortion or miscarriage.

The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception.

Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Starting levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception.

Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 ) ].

2.2Dosing levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets is one orange tablet daily for 84 consecuti… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 129 words ▾

3 DOSAGE FORMS AND STRENGTHS Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP consist of 84 orange tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 mustard tablets containing 0.01 mg ethinyl estradiol. ( 3 ) Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are available in Extended-Cycle Wallet, each containing a 13-week supply of tablets: 84 orange tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 mustard tablets each containing 0.01 mg of ethinyl estradiol.

The orange tablets are round biconvex, film-coated tablets debossed with 'LU' on one side and 'T41' on the other side. The mustard colored round biconvex, film-coated tablets debossed with 'LU' on one side and 'V22' on the other side.

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases.

Examples include females who are known to: ο Smoke, if over age 35 [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] ο Have current or history of deep vein thrombosis or pulmonary embolism. [ see Warnings and Precautions ( 5.1 ) ] ο Have cerebrovascular disease [ see Warnings and Precautions ( 5.1 ) ] ο Have coronary artery disease [ see Warnings and Precautions ( 5.1 ) ] ο Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [ see Warnings and Precautions ( 5.1 ) ] ο Have inherited or acquired hypercoagulopathies [ see Warnings and Precautions ( 5.1 ) ] ο Have uncontrolled hypertension or hypertension with vascular disease [ see Warnings and Precautions ( 5.5 ) ] ο Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [ see Warnings and Precautions ( 5.7 ) ] ο Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [ see Warnings and Precautions ( 5.8 ) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [ see Warnings and Precautions ( 5.11 ) ] Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [ see Warnings and Precautions ( 5.2 ) ].

Undiagnosed abnormal uterine bleeding [ see Warnings and Precautions ( 5.8 ) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [ see Warnings and Precautions ( 5.4 ) ].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.

Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in females with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly.

( 5.3 ) Gallbladder disease: May cause or worsen gallbladder disease. ( 5.6 ) Adverse carbohydrate and lipid metabolic effects: Monitor glucose in prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias.

( 5.7 ) Headache: Evaluate significant change in headaches and discontinue if indicated. ( 5.8 ) Uterine bleeding: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

( 5.9 )

5.1Thromboembolic Disorders and Other Vascular Conditions Stop levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets if an arterial or deep venous thrombotic/thromboembolic event occurs. Stop levonorgestrel and Ethinyl Estradiol Tablets 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 levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets during prolonged immobilization.

If feasible, stop levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets at least 4 weeks before and through 2 weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. Start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets no earlier than 4 weeks after delivery, in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

Before starting levonorgestrel and ethinyl estradiol tablets 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. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females with a high risk of arterial or venous/thromboembolic diseases [ see Contraindications ( 4 ) ]. 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. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in women over 35 years of age who smoke [ see Contraindications ( 4 ) ]. 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 ( 4 ) ].

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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions in clinical trials for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet were headaches, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting and back pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 and FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [ see Boxed Warning and Warning and Precautions ( 5.1 ) ] Vascular events [ see Warnings and Precautions ( 5.1 ) ] Liver disease [ see Warnings and Precautions ( 5.2 ) ]

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets was a 12-month, multicenter, non-comparative open-label study, which enrolled women aged 18-41, of whom 2,185 took at least one dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.

Adverse Reactions Leading to Study Discontinuation 11% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions leading to discontinuation were irregular and/or heavy uterine bleeding, headache, mood changes, nausea, acne, and weight gain. Common Treatment-Emergent Adverse Reactions (≥ 5% of women) headaches (33%); irregular and/or heavy uterine bleeding (13%), dysmenorrhea (11%), nausea and/or vomiting (11%), back pain (8%).

6.2Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 3). 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 3: 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. .

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. ( 7.1 ) 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 formal drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.

7.1Effects of Other Drugs on Combined Oral Contraceptives. Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 4 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Table 4: Significant Drug Interactions Involving Substances That Affect COCs a Induction potency of St.

John's wort may vary widely based on preparation. 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 a , 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 decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., bocep… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Discontinue use if pregnancy occurs. ( 8.1 ) Lactation: Advise use of another method. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet is not recommended for nursing mothers; may decrease milk production. ( 8.2 )

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

8.2Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established.

When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [ See Dosage and Administration ( 2.1 ) ].The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition.

8.4Pediatric Use Safety and efficacy of levonorgestrel and Ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.

8.5Geriatric Use Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population.

8.6Hepatic Impairment The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, COCs may be poorly metabolized in patients with hepatic impairment. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [ See Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ].

🤰 Pregnancy 90 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

🧒 Pediatric Use 57 words ▾

8.4Pediatric Use Safety and efficacy of levonorgestrel and Ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.

🧓 Geriatric Use 26 words ▾

8.5Geriatric Use Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population.

🆘 Overdosage 29 words ▾

10 OVERDOSAGE There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action COCs prevent pregnancy primarily by suppressing ovulation.

12.2Pharmacodynamics No pharmacodynamic studies were conducted with Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets.

12.3Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 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 systemic bioavailability of ethinyl estradiol is approximately 43%.

The mean plasma pharmacokinetic parameters of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following a single oral dose of three levonorgestrel/ethinyl estradiol combination tablets in normal healthy women under fasting conditions are reported in Table 6. Table 6: Mean (SD) Pharmacokinetic Parameters Following a Single Dose Administration of Three Tablets of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets in 30 Healthy Women under Fasting Conditions AUC 0-∞ = area under the drug concentration curve from time 0 to infinity C max = maximum concentration T max = time to maximum concentration AUC 0-∞ C max T max T ½ Levonorgestrel 76.5 ± 24.9 ng*hr/mL 6.0 ± 1.6 ng/mL 1.6 ± 0.6 hours 28.5 ± 8.7 hours Ethinyl estradiol 1335.8 ± 365.3 pg*hr/mL 122.8 ± 39.5 pg/mL 1.8 ± 0.7 hours 17.5 ± 7.4 hours The effect of food on the rate and the extent of levonorgestrel and ethinyl estradiol absorption following oral administration of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been evaluated.

Distribution The apparent volume of distribution of levonorgestrel and ethinyl estradiol is reported to be approximately

1.8 L/kg and

4.3L/kg, respectively. Levonorgestrel is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinyl estradiol is about 95 to 97% bound to serum albumin.

Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of combination levonorgestrel/ethinyl estradiol OCs, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by ethinyl estradiol, and a possible reduction in hepatic metabolic capacity. Metabolism Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma.

Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. 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.

First-pass metabolism of ethinyl estradiol involves formation of ethinyl estradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed ethinyl estradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of ethinyl estradiol hydroxylation. Hydroxylation at the 4-, 6-, and 16- positions may also occur, although to a much lesser extent than 2-hydroxylation.

The various hydroxylated metabolites are subject to further methylation and/or conjugation. Excretion About 45%… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 195 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in Extended-Cycle Wallets, that contains 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol and 7 mustard tablets each containing 0.01 mg of ethinyl estradiol. Orange tablets are round biconvex, film-coated tablets, debossed with "LU" on one side and "T41" on the other side. Mustard tablets are round biconvex, film-coated tablets debossed with "LU" on one side and "V22" on the other side.

They are supplied as follows: Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in an extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-848-11). Such two pouches are packed in a carton (NDC 68180-848-13). Storage and Handling Store at 25° C (77° F); excursions permitted to 15°to 30° C (59°to 86° F) [see USP Controlled Room Temperature] The tablets should not be removed from the protective blister packaging to avoid damage to the product.

The wallet card should be kept in the pouch until dispensed to the patient.

📋 Description 156 words ▾

11 DESCRIPTION Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.

Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets, USP, 0.01 mg meets USP Dissolution Test 2.

Levonorgestrel Footer

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use. Women who are over 35 years old and smoke should not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ].

Venous Thromboembolism Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [ see Warnings and Precautions ( 5.1 ) ]. Use during Pregnancy Instruct females to stop further intake of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if pregnancy is confirmed during treatment. Sexually Transmitted Infections Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

Dosing and Missed Pill Instructions Patients should take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed. See, "What to do if you miss pills" section of FDA-Approved Instructions for Use [ see Dosage and Administration ( 2.3 ) ].

Need for Additional Contraception Postpartum females who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets need to use an additional method of contraception until they have taken an orange tablet for 7 consecutive days [ see Dosage and Administration ( 2.2 ) ]. There is a need to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [ see Drug Interactions ( 7.1 ) ].

Lactation Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may reduce breast milk production. This is less likely to occur if breastfeeding is well established. When possible, nursing women should use other methods of contraception until they have discontinued breastfeeding [ see Use in Specific Populations ( 8.2 ) ].

Amenorrhea and Possible Symptoms of Pregnancy Amenorrhea may occur [ see Warnings and Precautions ( 5.9 ) ]. Advise patients to contact a healthcare provider in the event of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast tenderness. Depression Depressed mood and depression may occur.

Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [ see Warnings and Precautions ( 5.10 ) ]. Distributed by: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: December 2025 logo

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Levonorgestrel and Ethinyl Estradiol Tablet and Ethinyl Estradiol Tablet WARNING TO WOMEN WHO SMOKE Do not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from 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 the most important information I should know about Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets? Do not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from 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 Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets? levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How does levonorgestrel and ethinyl estradiol tablets 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 more carefully you follow the directions, the less chance you have of getting pregnant.

Based on the results of a single clinical study lasting 12 months, 2 to 4 women, out of 100 women, may get pregnant during the first year they use Levonorgestrel and Ethinyl Estradiol Tablets 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets?

Do not take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if you: smoke and are over 35 years of age have or had blood clots in your arms, legs, eyes or lungs had a stroke had a heart attack have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart have an inherited problem with your blood that makes it clot more than normal have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems have diabetes and are over the age of 35; have diabetes with high blood pressure; kidney, eye, nerve, or blood vessel damage; or for more than 20 years have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over the age of 35 have or had breast cancer have liver disease, including liver tumors have unexplained vaginal bleeding 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 to you while you are taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, stop taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spe… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 112 words ▾

8.2Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established.

When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [ See Dosage and Administration ( 2.1 ) ].The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES In a 12-month multicenter open-label clinical trial, 2,185 women aged 18-41 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, completing the equivalent of 20,937 28-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (75%), African-American (12%), Hispanic (10%), Asian (2%), and Other (2%). There were no exclusions for body mass index (BMI) or weight.

The weight range for those women treated was 87 to 381 lbs., with a mean weight of 159 lbs. Among the women in the trial, 59% were current or recent hormonal contraceptive users, 30% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment) and 11% were new starts. Of treated women, 14.2% were lost to follow-up, 11.6% discontinued due to an adverse event, and 10.3% discontinued by withdrawing their consent.

The pregnancy rate (Pearl Index [PI]) in women aged 18 to 35 years was 2.74 pregnancies per 100 women-years of use (95% confidence interval 1.92 – 3.78), based on 36 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.

🧪 Nonclinical Toxicology 20 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [ See Warnings and Precautions ( 5.2 , 5.11 ) ]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [ See Warnings and Precautions ( 5.2 , 5.11 ) ]

📄 Patient Package Insert 8 words ▾

SPL PATIENT PACKAGE INSERT FDA Approved Patient Labeling

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS How do I take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets? Take one pill every day at the same time. If you miss pills you could get pregnant.

This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your 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, you could also feel a little sick to your stomach. If you have trouble remembering to take levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking Levonorgestrel and Ethinyl Estradiol tablets and Ethinyl Estradiol tablets Decide what time of day you want to take your pill. It is important to take it at about the same time every day. Look at your Extended-Cycle Wallet.

Your wallet consists of blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 orange pills and 7 mustard pills. Blister strip 1 and 2 each contain 28 orange pills (4 rows of 7 pills).

Blister strip 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 mustard pills (1 row of 7 pills). 3. Also find: Where on the first strip in the pack to start taking pills (upper left corner at the start arrow) and In what order to take the pills (follow the weeks and arrow).

4. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills. When to Start Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Take the first orange pill on the Sunday after your period starts, even if you are still bleeding.

If your period begins on Sunday, start the first orange pill that same day. Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first orange pill until the next Sunday (first 7 days). If you are switching from another birth control method: If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days.

If you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. How to Take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Take one pill at the same time every day until you have taken the last pill in the wallet. Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).

Do not skip pills even if you do not have sex very often. When you finish a wallet After taking the last mustard pill, start taking the first orange pill from a new Extended-Cycle Wallet the very next day (this should be on a Sunday) regardless of when your period started. If you miss your scheduled period when you are taking the mustard pills, contact your healthcare provider because you may be pregnant.

If you are pregn… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 128 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL levonorgestrel/ethinyl estradiol 0.1 mg/0.02 mg tablets ethinyl estradiol 0.01 mg tablets Rx only Usual Dosage: One tablet daily for 91 consecutive days in the following order: 84 orange tablets followed by 7 mustard tablets as prescribed. See enclosed package brochure. Pharmacist: Dispense patient information with each prescription.

Contains 2 Extended-Cycle Wallets, each containing 91 tablets: 84 orange tablets, each containing 0.1 mg levonorgestrel with 0.02 mg ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg ethinyl estradiol. THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

Store at 25º (77ºF); excursion permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. carton pouch label image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
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Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.