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levonorgestrel and ethinyl estradiol Kit, 3 pouches — NDC 68462-672-95 (Billing 68462-0672-95)

by Glenmark Pharmaceuticals Inc., USA · 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

This is a package of 3 pouches of levonorgestrel and ethinyl estradiol Kit from Glenmark Pharmaceuticals Inc., USA, marketed since Jun 2015 and currently FDA-listed; retail pharmacies pay about $0.2267 per pouche (NADAC). It is this product's only package size.

NDC 68462-0672-95
🏷️ FDA NDC (as labeled) 68462-672-95 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) 68462-672-95
Product NDC 68462-672
11-digit billing NDC 68462067295
NCPDP billing unit EA — each (per item)
RxCUI 238019, 748797, 751901
UPC 0368462672952
Application # ANDA203164
SPL Set ID 3d87d9a4-860a-4ea7-a993-0f4adf1789da
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-06-12
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 25993002300320
GPI class Levonorgest-Eth Estrad 91-Day
GCN Seq No 053076
GCN 20414
HICL code 001460
Ingredient (HICL) Levonorgestrel/Ethin.estradiol
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-ETH ESTRAD 0.15-0.03
FDB brand name Levonorgestrel-Eth Estradiol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053076
  • GCN: 20414
  • GPI-14 (Medi-Span): 25993002300320
  • HICL (First Databank): 001460
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 238019
Why two NDCs? The FDA registers this code as 68462-672-95 — 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 → 68462-0672-95. 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-ETH ESTRAD 0.15-0.03 Ingredient Levonorgestrel/Ethin.estradiol
📖 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 $0.227 $0.68 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.2810 $0.84 / 3 kit
Medicare drug plans payPart D · Q2 2026 $0.2151 $0.65 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.227 $0.149
▲ Up 1% over the last 24 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
68462-0672-95 You're viewing this Main listing 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2015-06-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued save 50%
Altavera 70700-0116-85 Xiromed, 1 kit $0.114 AB Availability likely save 50%
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.114 AB Availability likely save 50%
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.114 AB Availability likely save 50%
Marlissa 68462-0388-29 Glenmark 1 kit $0.114 AB Availability likely save 50%
Kurvelo 68180-0844-73 Lupin 63 tablets $0.114 AB Availability likely save 50%
Portia 00555-9020-58 Teva 6 pouches $0.114 — Availability likely save 50%
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely save 45%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued save 36%
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely save 33%
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued save 33%
Lessina 00555-9014-67 Teva 3 pouches $0.154 — Availability likely save 32%
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.154 AB1 Availability likely save 32%
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.154 AB1 Availability likely save 32%
Aviane 00555-9045-58 Teva 6 pouches $0.154 — Availability likely save 32%
Vienva 70700-0118-85 Xiromed, 1 kit $0.154 AB1 Availability likely save 32%
Falmina 16714-0359-01 Northstar 1 packet $0.154 AB1 Availability likely save 32%
Sronyx 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued save 23%
Introvale 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed save 19%
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed save 1%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed +0%
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 estradiolthis 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 +6%
Levonest 16714-0340-01 Northstar 1 packet $0.324 AB Availability likely +43%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.324 AB Availability likely +43%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 — Availability likely +265%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.445 AB3 Availability likely +1420%
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

🏛️
2015
On the market since
Jun 2015
📍
2026
Currently FDA-listed
11 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.

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

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA203164 (ANDA)
Labeler code68462
First marketedJun 2015
Product typeHuman Prescription Drug
Portfolio343 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 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 130 words ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel 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: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Levonorgestrel and ethinyl estradiol tablets are 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. ( 5.1 )

🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel 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 )

⏱️ 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. ( 2.1 ) • Take tablets in the order directed on the Extended-Cycle Tablet Dispenser. ( 2.2 )

2.1How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets Levonorgestrel and ethinyl estradiol tablets are dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling ( 16 )]. Levonorgestrel and ethinyl estradiol tablets should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets Starting levonorgestrel and ethinyl estradiol tablets in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • Levonorgestrel and ethinyl estradiol active tablets are light blue to blue (Day 1 to Day 84). • Levonorgestrel and ethinyl estradiol inactive tablets are white to off-white (Day 85 to Day 91).

Sunday Start: For each 91-day course, take in the following order: • Take the first light blue to blue tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment. • Take subsequent light blue to blue tablets once daily at the same time each day for a total of 84 days. • Take one white to off-white tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken.

A scheduled period should occur during the 7 days that the white to off-white tablets are taken. • Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol without interruption on the same day of the week (Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a light blue to blue tablet once a day for 84 days, and a white to off-white tablet once a day for 7 days. 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 a light blue to blue tablet daily for 7 consecutive days.

Switching from another contraceptive method to levonorgestrel and ethinyl estradiol tablets Start levonorgestrel and ethinyl estradiol tablets: Another oral contraceptive On the day when the new pack of the previous COC would have been started Transdermal patch On the day when the next application would have been scheduled. Vaginal ring On the day when the next insertion would have been scheduled. Injection On the day when the next injection would have been scheduled.

Intrauterine contraceptive (IUD) • On the day of removal. • If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course. Implant On the day of removal. Starting Levonorgestrel and Ethinyl Estradiol Tablets after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, levonorgestrel and ethinyl estradiol tablets may be started immediately.

An additional method of contraception is not needed if levonorgestrel and ethinyl estradiol tablets are started immediately. • If levonorgestrel and ethinyl estradiol tablets are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of levonorgestrel and ethinyl estradiol tablets. Second-… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 126 words ▾

3 DOSAGE FORMS AND STRENGTHS Levonorgestrel and Ethinyl Estradiol Tablets, USP are available as round, biconvex, film-coated tablets debossed with ' E1 ' on one side and plain on the other, packaged in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets in the following order: • 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP. • 7 white to off-white inert tablets debossed with ' E2 ' on one side and plain on the other. Levonorgestrel and Ethinyl Estradiol Tablets, USP consists of 84 round, light blue to blue tablets containing 0.15 mg of levonorgestrel, USP and 0.03 mg of ethinyl estradiol, USP and 7 round, white to off-white inert tablets.

( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Levonorgestrel and ethinyl estradiol tablets are 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: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )]. o Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )]. o Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] . o Have coronary artery disease [see Warnings and Precautions ( 5.1 )] . o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] . o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] . o Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ( 5.4 )] . o Have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see Warnings and Precautions ( 5.7 )] . o 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 ) and Use in Specific Populations ( 8.6 )] . • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]. • 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 ( 5.3 )]. • A high risk of arterial or venous thrombotic diseases ( 4 ) • Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis ( 4 ) • Undiagnosed abnormal uterine bleeding ( 4 ) • Breast cancer ( 4 ) • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 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 women with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly.

( 5.4 ) • Gallbladder disease: May cause or worsen gallbladder disease. ( 5.5 ) • Adverse carbohydrate and lipid effects: Monitor glucose in prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

( 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 if an arterial or venous thrombotic/thromboembolic event occurs. • Stop levonorgestrel and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. • Discontinue levonorgestrel and ethinyl estradiol during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol 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 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 likelihood of ovulation increases after the third postpartum week. • Before starting levonorgestrel and ethinyl estradiol 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 is contraindicated in females with a high risk of arterial or venous thrombotic/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 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 and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contra… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 clinical practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of levonorgestrel and ethinyl estradiol (345.14 woman-years of exposure) [see Clinical Studies (14) ] .

Adverse Reactions Leading to Study Discontinuation : 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the levonorgestrel and ethinyl estradiol group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%). Common Adverse Reactions (≥ 2% of women) : headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).

Serious Adverse Reactions: pulmonary embolus, cholecystitis.

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 to 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.

The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following adverse reactions have been identified during post-approval use of levonorgestrel and ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders : abdominal distension, vomiting General disorders and administration site conditions : chest pain, fatigue, malaise, edema peripheral, pain Immune system disorder: h ypersensitivity reactions, including itching, rash, and angioedema Investigations: blood pressure increased Musculoskeletal and connective tissue disorders : muscle spasms, pain in extremity Nervous system disorders : dizziness, loss of consciousness Psychiatric disorders : insomnia Reproductive and breast disorders : dysmenorrhea Skin and subcutaneous tissue disorders : alopecia Vascular disorders : thrombosis, pulmonary embolism, pulmonary thrombosis figure2

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.

Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol. Enzyme inducers (e.g.

CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol. ( 7.1 )

7.1Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Table 5 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets. Table 5: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers Clinical effect • Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. • Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding.

Prevention or management • Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. • Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort 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 [see Clinical Pharmacology ( 12.3 )] . • 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. a Induction potency of St. John’s wort may vary widely based on preparation.

Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20-25%. Ascorbic acid and acetaminophen may increase systemic exposure of EE possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of 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] or some HCV protease inhibitors (e.g. boceprevir and telaprevir) and some non-nucleosidase reverse transcriptase inhibitors (e.g. nevirapine) In contrast, significant increases in systemic exposure o… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Discontinue if pregnancy occurs. ( 8.1 ) • Lactation: Advise use of another contraceptive method; levonorgestrel and ethinyl estradiol can decrease milk production. ( 8.2 )

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel 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 any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets or the underlying maternal condition.

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

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

8.6Hepatic Impairment The pharmacokinetics of levonorgestrel and ethinyl estradiol 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 are contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )].

🤰 Pregnancy 85 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel 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 52 words ▾

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

🧓 Geriatric Use 21 words ▾

8.5Geriatric Use Levonorgestrel and ethinyl estradiol has 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 specific pharmacodynamic studies were conducted with levonorgestrel and ethinyl estradiol.

12.3Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol 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. EE is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of EE is approximately 43%.

Following continuous dosing with once-daily administration of levonorgestrel and ethinyl estradiol tablets, plasma concentrations of levonorgestrel and EE reached steady-state within 7 days. The mean plasma pharmacokinetic parameters for levonorgestrel and ethinyl estradiol under fasting conditions in normal healthy women following once-daily administration of one levonorgestrel/EE combination tablet for 10 days are summarized in Table 7. Table 5: Mean ±SD Pharmacokinetic Parameters Under Fasting Conditions in Healthy Women Following 10 Days Administration of One Tablet of Levonorgestrel and Ethinyl Estradiol (n=44) a C avg = AUC 0 to 24/24 Analyte AUC 0 to 24 C max C min C avg a T max Levonorgestrel 54.6 ± 16.5 ng*hr/mL 5 ± 1.5 ng/mL 1.6 ± 0.5 ng/mL 2.3 ± 0.7 ng/mL 1.4 ± 0.7 hours Ethinyl estradiol 935.5 ± 346.9 pg*hr/mL 106.1 ± 41.2 pg/mL 18.5 ± 9.4 pg/mL 38.9 ± 14.4 pg/mL 1.6 ± 0.6 hours Food Effect The effect of food on the rate and the extent of levonorgestrel and EE absorption following oral administration of levonorgestrel and ethinyl estradiol has not been evaluated.

Distribution The apparent volume of distribution of levonorgestrel and EE are 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. EE is about 95 to 97% bound to serum albumin.

EE does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of levonorgestrel/EE oral contraceptives, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by EE, and a possible reduction in hepatic metabolic capacity. Metabolism Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate 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 EE involves formation of EE-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed EE by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of EE 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% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of levonorgestrel and ethinyl estrad… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 11 words ▾

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

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: • 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP, and 7 white to off-white inert tablets. The active light blue to blue tablets are round, biconvex, film-coated tablets debossed with ‘ E1 ’ on one side and plain on the other. • 7 inert white to off-white, round, biconvex, uncoated tablets debossed with ‘ E2 ’ on one side and plain on the other.

1 carton (NDC 68462-672-95) containing 3 foil pouches (NDC 68462-672-91). Each pouch contains 1 Extended-Cycle Dispenser (NDC 68462-672-91). Storage and Handling • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. • Protect from light

📋 Description 163 words ▾

11 DESCRIPTION Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 MW: 312.45 Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.

Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. • Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no.

10 aluminum lake. • Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate. levonorgestrel eestructure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). 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 [see Boxed Warning and Warnings and Precautions ( 5.1 )] .

Venous Thromboembolism The 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 if pregnancy is confirmed during treatment. Sexually Transmitted Infections Levonorgestrel 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 [see Dosage and Administration ( 2.1 )] . • Instruct patients what to do in the event tablets are missed. See “What should I do if I miss any levonorgestrel and ethinyl estradiol tablets pills” section in FDA-approved Instructions for Use [see Dosage and Administration ( 2.3 )] . Need for Additional Contraception • Postpartum females who start levonorgestrel and ethinyl estradiol tablets who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets need to use an additional method of contraception until they have taken a light blue to blue tablet for 7 consecutive days [see Dosage and Administration ( 2.1 )] . • There is a need for a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets [see Drug Interactions ( 7.1 )] .

Lactation Levonorgestrel 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. Because women using levonorgestrel and ethinyl estradiol tablets will likely have scheduled bleeding only 4 times per year, advise women to contact their health care provider in the event of amenorrhea with symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions ( 5.9 )] . 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: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com May 2025 FDA-approved Patient Labeling Patient Information Levonorgestrel and Ethinyl Estradiol (LEE-voe-nor-JES-trel and ETH-i-nil ES-tra-DYE-ol) Tablets, USP WARNING TO WOMEN WHO SMOKE Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old.

Smoking increases your risk of serious cardiovascular side effects from 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?

Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from 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? Lev… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol 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. EE is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of EE is approximately 43%.

Following continuous dosing with once-daily administration of levonorgestrel and ethinyl estradiol tablets, plasma concentrations of levonorgestrel and EE reached steady-state within 7 days. The mean plasma pharmacokinetic parameters for levonorgestrel and ethinyl estradiol under fasting conditions in normal healthy women following once-daily administration of one levonorgestrel/EE combination tablet for 10 days are summarized in Table 7. Table 5: Mean ±SD Pharmacokinetic Parameters Under Fasting Conditions in Healthy Women Following 10 Days Administration of One Tablet of Levonorgestrel and Ethinyl Estradiol (n=44) a C avg = AUC 0 to 24/24 Analyte AUC 0 to 24 C max C min C avg a T max Levonorgestrel 54.6 ± 16.5 ng*hr/mL 5 ± 1.5 ng/mL 1.6 ± 0.5 ng/mL 2.3 ± 0.7 ng/mL 1.4 ± 0.7 hours Ethinyl estradiol 935.5 ± 346.9 pg*hr/mL 106.1 ± 41.2 pg/mL 18.5 ± 9.4 pg/mL 38.9 ± 14.4 pg/mL 1.6 ± 0.6 hours Food Effect The effect of food on the rate and the extent of levonorgestrel and EE absorption following oral administration of levonorgestrel and ethinyl estradiol has not been evaluated.

Distribution The apparent volume of distribution of levonorgestrel and EE are 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. EE is about 95 to 97% bound to serum albumin.

EE does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of levonorgestrel/EE oral contraceptives, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by EE, and a possible reduction in hepatic metabolic capacity. Metabolism Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate 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 EE involves formation of EE-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed EE by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of EE 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% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of levonorgestrel and ethinyl estradiol was about 30 hours.

EE is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of EE after a single dose of levonorgestrel… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with levonorgestrel and ethinyl estradiol.

🔬 Clinical Studies 203 words ▾

14 CLINICAL STUDIES In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18 to 40 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol, completing 809 91-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (77%), African-American (11%), Hispanic (7%), Asian (2%), and Other (3%). There were no exclusions for body mass index (BMI) or weight.

The weight range of those women treated was 84 to 304 pounds, with a mean weight of 157 pounds and a median weight of 147 pounds. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 29% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 8% were new starts. The pregnancy rate (Pearl Index [PI]) in the 397 women aged 18 to 35 years was 1.98 pregnancies per 100 women-years of use (95% CI: 0.54 to 5.03), based on 4 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 back-up contraception, were not included in the calculation of the PI.

🧪 Nonclinical Toxicology 18 words ▾

13 NONCLINICAL TOXICOLOGY

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

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 15 words ▾

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

📖 Instructions for Use ~3 min read ▾

Instructions for Use Levonorgestrel and Ethinyl Estradiol (LEE-voe-nor-JES-trel and aETH-i-nil ES-tra-DYE-ol) Tablets, USP Important Information about taking levonorgestrel and ethinyl estradiol tablets • Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser. • Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant.

The more pills you miss, the more likely you are to get pregnant. • If you have trouble remembering to take levonorgestrel and ethinyl estradiol tablets, talk to your healthcare provider. • When you first start taking levonorgestrel and ethinyl estradiol tablets, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. • You may feel sick to your stomach (nauseous), especially during the first few months of taking levonorgestrel and ethinyl estradiol tablets.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider. • Missing pills can also cause spotting or light bleeding, even when you take the missed pills later.

On the days you take 2 pills to make up for missed pills (see, “What should I do if I miss any levonorgestrel and ethinyl estradiol tablets?” below), you could also feel a little sick to your stomach. • It is not uncommon to miss a period. However, if you miss a period and have not taken levonorgestrel and ethinyl estradiol tablets according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking levonorgestrel and ethinyl estradiol tablets. • If you have vomiting or diarrhea within 3 to 4 hours of taking a light blue to blue pill, take another light blue to blue pill as soon as possible.

Continue taking one pill a day until the 91-day course is finished. • If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider. • Stop taking levonorgestrel and ethinyl estradiol tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.

Before you start taking levonorgestrel 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 Tablet Dispenser. Your Tablet Dispenser consists of 3 blister cards that hold 91 individually sealed pills (a 13-week or 91-day cycle).

The 91 pills consist of 84 light blue to blue and 7 white to off-white pills. Blister cards 1 and 2 each contain 28 light blue to blue pills (4 rows of 7 pills). See Figure A.

Blister card 3 contains 35 pills consisting of 28 light blue to blue pills (4 rows of 7 pills) and 7 white to off-white pills (1 row of 7 pills). See Figure B. Figure A Figure B • Also find: o Where on the first blister card in the pack to start taking pills (upper left corner) and o In what order to take the pills (follow the weeks) • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking levonorgestrel and ethinyl estradiol tablets? If you start taking levonorgestrel and ethinyl estradiol tablets and you have not used a hormonal birth control method before: • Take the first light blue to blue pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first light blue to blue pill that same day. • Use another method of birth control (such as condoms or spermicides) as a back-up met… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 44 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL pouch

Package/Label Display Panel NDC 68462-672-95 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
17.4K
Units reimbursed last 4 qtrs
1.6M
Gross reimbursed last 4 qtrs
$445.4K
Avg / prescription
$25.54
Avg / unit
$0.2810
Latest quarter Q1 2026
4.2KRx
Medicaid pays / ea
$0.2810
gross reimbursed
vs
NADAC / ea
$0.2267
acquisition cost
=
Spread
+$0.0543
+24% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
36% FFS 64% MCO
Fee-for-service · 6,321 Rx Managed care · 11,116 Rx
State Medicaid map
Alaska: no data reported AK Maine: 13,923 units · 998 per 100k residents ME Washington: 24,479 units · 313 per 100k residents WA Idaho: 13,650 units · 695 per 100k residents ID Montana: 6,552 units · 579 per 100k residents MT North Dakota: no data reported ND Minnesota: 75,166 units · 1,310 per 100k residents MN Wisconsin: 84,350 units · 1,427 per 100k residents WI Michigan: 143,306 units · 1,428 per 100k residents MI New York: 128,427 units · 656 per 100k residents NY Vermont: 9,919 units · 1,533 per 100k residents VT New Hampshire: 19,383 units · 1,383 per 100k residents NH Oregon: 16,016 units · 378 per 100k residents OR Nevada: 7,917 units · 248 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 29,484 units · 919 per 100k residents IA Illinois: 57,582 units · 459 per 100k residents IL Indiana: 31,486 units · 459 per 100k residents IN Ohio: 81,928 units · 695 per 100k residents OH Pennsylvania: 85,358 units · 659 per 100k residents PA New Jersey: 6,006 units · 64.7 per 100k residents NJ Massachusetts: 31,304 units · 447 per 100k residents MA California: 104,826 units · 269 per 100k residents CA Utah: no data reported UT Colorado: 30,394 units · 517 per 100k residents CO Nebraska: 19,411 units · 981 per 100k residents NE Missouri: 28,574 units · 461 per 100k residents MO Kentucky: 46,319 units · 1,023 per 100k residents KY West Virginia: no data reported WV Virginia: 29,939 units · 343 per 100k residents VA Maryland: 26,390 units · 427 per 100k residents MD Connecticut: 7,096 units · 196 per 100k residents CT Rhode Island: 6,552 units · 598 per 100k residents RI Arizona: 15,288 units · 206 per 100k residents AZ New Mexico: 21,385 units · 1,012 per 100k residents NM Kansas: 11,284 units · 384 per 100k residents KS Arkansas: 6,825 units · 223 per 100k residents AR Tennessee: 46,136 units · 647 per 100k residents TN North Carolina: 123,725 units · 1,142 per 100k residents NC South Carolina: 32,851 units · 611 per 100k residents SC Delaware: 5,642 units · 547 per 100k residents DE Oklahoma: 15,106 units · 373 per 100k residents OK Louisiana: 41,405 units · 905 per 100k residents LA Mississippi: 6,188 units · 210 per 100k residents MS Alabama: 11,557 units · 226 per 100k residents AL Georgia: 27,936 units · 253 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 30,121 units · 98.7 per 100k residents TX Florida: 23,660 units · 105 per 100k residents FL
Units reimbursed · per 100k residents
64.71,533
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 1,533 /100k
2 Michigan 1,428 /100k
3 Wisconsin 1,427 /100k
4 New Hampshire 1,383 /100k
5 Minnesota 1,310 /100k
6 North Carolina 1,142 /100k
7 Kentucky 1,023 /100k
8 New Mexico 1,012 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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.
Is this package still being marketed?
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 Glenmark Pharmaceuticals Inc., USA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Glenmark Pharmaceuticals Inc., USA 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.
← 68462-0659-27 · Glenmark 68462-0678-10 · Glenmark →
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.