MARLISSA Levonorgestrel and Ethinyl Estradiol Kit — NDC 68462-0388-29 package photo

MARLISSA Levonorgestrel and Ethinyl Estradiol Kit

by Glenmark Pharmaceuticals Inc., USA · 3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84)
NDC 68462-0388-29
🏷️ FDA NDC (as labeled) 68462-388-29 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68462-388-29
Product NDC 68462-388
11-digit billing NDC 68462038829
NCPDP billing unit EA — each (per item)
UPC 0368462388297
Application # ANDA091452
SPL Set ID 9379d99e-c416-4dab-a817-1c110e0d4b93
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-02-29
Dosage form KIT
GPI-14 25990002400310
GPI class Marlissa
GCN Seq No 003314
GCN 11530
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 MARLISSA-28 TABLET
FDB brand name Marlissa
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68462-388-29 — 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 → 68462-0388-29. 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.

🏭 Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA091452 (ANDA)
Labeler code68462
First marketedFeb 2012
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.

🩺 Clinical

Label name MARLISSA-28 TABLET 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 mainly by stopping your ovaries from releasing an egg. It also thickens the cervical mucus so sperm can't easily get through, and changes the uterine lining a...
  • What exactly does this medication do, and how well does it work?
  • The most common ones in the first few months are headaches, nausea, irregular bleeding or spotting, breast tenderness, and mood changes. Most of these tend to settle down after you...
  • Are there any side effects I should expect when I first start?
📖 Read our full Ethinyl Estradiol / Levonorgestrel guide →
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.

💊 What it looks like

Color Orange / Pink
ShapeRound
ImprintA6
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.

💲 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 $0.113 $0.34 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.2362 $0.71 / 3 kit
Medicare drug plans payPart D · Q2 2026 $0.2200 $0.66 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.209 $0.109
▼ Down 46% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Altavera 70700-0116-85 Xiromed, 1 kit $0.113 AB Availability likely
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.113 AB Availability likely
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.113 AB Availability likely
Marlissathis 68462-0388-29 Glenmark 1 kit $0.113 AB Availability likely
Kurvelo 68180-0844-73 Lupin 63 tablets $0.113 AB Availability likely
Portia 00555-9020-58 Teva 6 pouches $0.113 Availability likely
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely +10%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued +28%
Lessina 00555-9014-67 Teva 3 pouches $0.151 Availability likely +34%
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.151 AB1 Availability likely +34%
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.151 AB1 Availability likely +34%
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely +34%
Aviane 00555-9045-58 Teva 6 pouches $0.151 Availability likely +34%
Vienva 70700-0118-85 Xiromed, 1 kit $0.151 AB1 Availability likely +34%
Falmina 16714-0359-01 Northstar 1 packet $0.151 AB1 Availability likely +34%
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued +35%
Sronyx 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued +54%
Introvale 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed +63%
Setlakin 16714-0366-03 Northstar 3 pouches $0.221 AB Availability likely +96%
Levonorgestrel and Ethinyl Estradiol 68180-0843-13 Lupin 1 kit $0.221 AB Availability likely +96%
levonorgestrel and ethinyl estradiol 68462-0672-95 Glenmark 3 pouches $0.221 AB Availability likely +96%
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed +99%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed +101%
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 Lupin 2 pouches $0.239 AB Availability likely +112%
Levonest 16714-0340-01 Northstar 1 packet $0.339 AB Availability likely +201%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.339 AB Availability likely +201%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 Availability likely +634%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.442 AB3 Availability likely +2952%
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

🏛️
2012
On the market since
Feb 2012
📍
2026
Currently FDA-listed
14 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.

🗺️ 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 68462-0388-29, 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 – Q4 2025 · 4 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
12.3K
Units reimbursed last 4 qtrs
783.2K
Gross reimbursed last 4 qtrs
$185K
Avg / prescription
$14.99
Avg / unit
$0.2362
Latest quarter Q4 2025
3KRx
Medicaid pays / ea
$0.2362
gross reimbursed
vs
NADAC / ea
$0.1128
acquisition cost
=
Spread
+$0.1234
+109% 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
66% FFS 34% MCO
Fee-for-service · 8,124 Rx Managed care · 4,213 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 22,289 units · 285 per 100k residents WA Idaho: no data reported ID Montana: 2,436 units · 215 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,792 units · 31.2 per 100k residents MN Wisconsin: no data reported WI Michigan: 3,920 units · 39.1 per 100k residents MI New York: 14,818 units · 75.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 9,520 units · 225 per 100k residents OR Nevada: 18,648 units · 584 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 700 units · 21.8 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,540 units · 13.1 per 100k residents OH Pennsylvania: 9,352 units · 72.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 543,856 units · 1,396 per 100k residents CA Utah: 1,428 units · 41.8 per 100k residents UT Colorado: 784 units · 13.3 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 1,400 units · 22.7 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 28,056 units · 378 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,268 units · 20.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 10,388 units · 227 per 100k residents LA Mississippi: 616 units · 21.0 per 100k residents MS Alabama: 5,292 units · 104 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 19,040 units · 1,327 per 100k residents HI Texas: 40,600 units · 133 per 100k residents TX Florida: 44,492 units · 197 per 100k residents FL
Units reimbursed · per 100k residents
13.11,396
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 California 1,396 /100k
2 Hawaii 1,327 /100k
3 Nevada 584 /100k
4 Arizona 378 /100k
5 Washington 285 /100k
6 Louisiana 227 /100k
7 Oregon 225 /100k
8 Montana 215 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Marlissa — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Marlissa. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.6K
Claims incl. refills
288
Beneficiaries
181
Spend / beneficiary
$36.61
Spend / claim
$23.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MARLISSA (this brand).

Top reported reactions

Nausea51
Headache42
Fatigue36
Dizziness34
Vomiting33
Anxiety26
Pulmonary Embolism26

Age at onset

Adolescent7
Adult58
Elderly1

Reporter sex

666 reports
Male · 1%
Female · 98%
Unknown · 0%

Serious outcomes

Hospitalization197
Death20
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 49 9
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68462-0388-29 You're viewing this 3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) 2012-02-29 Active

🧭 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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ 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 FDA registers it as 68462-388-29, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68462-0388-29, written without dashes as 68462038829. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68462-0388-29, the first segment (68462) is the labeler code FDA assigned to Glenmark Pharmaceuticals Inc., USA; the middle segment (0388) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (29) identifies this exact package size and type. Together they name one specific package of one specific product.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 68 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 MARLISSA ® , are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].

🎯 Indications and Usage 22 words

INDICATIONS AND USAGE MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION 1. How to Start and Take MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED ). MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may be started using either a Day 1 start or a Sunday start (see Table 3).

For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 3: Instructions for Administration of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) in females with no current use of hormonal contraception Day 1 start • Take first tablet without regard to meals on the first day of menses • Take subsequent tablets once daily at the same time each day • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Sunday start • Take first tablet without regard to meals on the first Sunday after the onset of menstrual period • Take subsequent tablets once daily at the same time each day • Use additional nonhormonal contraception for the first seven days of product use • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Switching from another contraceptive method • A COC Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets): • On the day when the new pack of the previous COC would have been started • Transdermal patch • On the day when next application would have been scheduled • Vaginal ring • On the day when next insertion would have been scheduled • Injection • On the day when next injection would have been scheduled • Intrauterine contraceptive • On the day of removal • Implant • On the day of removal Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) may be started immediately.

An additional method of contraception is not needed if MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is started immediately. • If MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets). Second-trimester • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.

Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS , WARNINGS (1), PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING ) . Starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) after Childbirth • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.

Start contraceptive therapy with MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for women not currently using hormonal contraception. • MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is not recommended for use in lactating women (see PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING ). • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS , WARNINGS (9), PRECAUTIONS (6) and FDA‑ APPROVED P…

Contraindications ~1 min read

CONTRAINDICATIONS MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females who are known to have the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1)]. o Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1)]. o Have cerebrovascular disease [see WARNINGS (1)]. o Have coronary artery disease [see WARNINGS (1)]. o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1)]. o Have inherited or acquired hypercoagulopathies [ see WARNING S (1)]. o Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3)]. o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7)]. o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8)]. • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive. • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see WARNINGS (2)]. • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS (5)]. • Undiagnosed abnormal uterine bleeding [see WARNINGS (9)].

⚠️ Warnings ~3 min read

WARNINGS 1. Thromboembolic Disorders and Other Vascular Conditions • Stop MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if an arterial or venous thrombotic/thromboembolic event occurs. • Stop MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. • Discontinue MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) during prolonged immobilization.

If feasible, stop MARLISSA ® at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. • Start MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) no earlier than four weeks after delivery in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. • Before starting MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.

MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases (see CONTRAINDICATIONS ). Arterial Events COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.

MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS ). Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

Venous Events Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS ). While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1).

The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well.

The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.

Figure 1: Likelihood of Developing a VTE Figure1.jpg 2. Liver Disease Elevated Liver Enzymes MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS ). Discontinue MARLISSA ® if jaundice develops.

Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded. Liver Tumors MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular adverse events [see BOXED WARNING and WARNINGS (1)] • Vascular events [see WARNINGS (1)] • Liver disease [see WARNINGS (2)] • Hypertension [see WARNINGS (3)] • Gallbladder disease [see WARNINGS (6)] • Carbohydrate and lipid effects [see WARNINGS (7)] • Headache [see WARNINGS (8)] • Carcinoma of the cervix [see WARNINGS (11)] Adverse reactions reported by COC users and described elsewhere in the labeling are: • Bleeding irregularities and amenorrhea [see WARNINGS (9)] • Mood changes, including depression [see WARNINGS (10)] • Melasma/chloasma which may persist [see WARNINGS (14)] • Edema/fluid retention [see PRECAUTIONS (2)] • Diminution in lactation when given immediately postpartum [see PRECAUTIONS (7)] Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 2).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use.

Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.

Figure-2

🆘 Overdosage 27 words

OVERDOSAGE There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.

🧬 Clinical Pharmacology 11 words

CLINICAL PHARMACOLOGY Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

📦 How Supplied / Storage and Handling 115 words

HOW SUPPLIED/ STORAGE AND HANDLING MARLISSA ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg) is available in cartons (NDC 68462-388- 29) of 3 blisters (NDC 68462-388-84), each containing 28 tablets. Each blister contains: 21 Active Tablets: Light orange to orange color, round, biconvex, film coated tablets with ‘A5’ debossed on one side. 7 Inert Tablets: Light pink to pink color, round, biconvex, uncoated tablets with ‘A6’ debossed on one side.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?

1 (888) 721-7115 www.glenmarkpharma-us.com April 2025 logo2

📋 Description 164 words

DESCRIPTION MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 MW: 312.4 Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.

Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol.

Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. StructureLevonorgestrel.jpg StructureEE.jpg

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