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Gwyn Lo norelgestromin and ethinyl estradiol 220 ug/d; 20 ug/d Patch — NDC 49502-0627-62 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gwyn Lo norelgestromin and ethinyl estradiol 220 ug/d; 20 ug/d Patch — NDC 49502-627-62 (Billing 49502-0627-62)

by Viatris Specialty LLC · 3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 7 d in 1 PATCH

This is a package of Gwyn Lo norelgestromin and ethinyl estradiol 220 ug/d; 20 ug/d Patch from Viatris Specialty LLC, marketed since Oct 2026 and currently FDA-listed. It is this product's only package size.

NDC 49502-0627-62
🏷️ FDA NDC (as labeled) 49502-627-62 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 49502-627-62 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49502 labeler · 627 product · 62 package
Package marketed since
Oct 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4950262762 0
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49502-627-62
Product NDC 49502-627
11-digit billing NDC 49502062762
NCPDP billing unit EA — each (per item)
Application # NDA219990
SPL Set ID e92741f4-87fe-429f-b5b5-c558ed5f4fa9
Established class (EPC) Estrogen; Progestin
Mechanism of action Estrogen Receptor Agonists
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-10-01
Route TRANSDERMAL
Dosage form PATCH
Substance NORELGESTROMIN; ETHINYL ESTRADIOL
Why two NDCs? The FDA registers this code as 49502-627-62 — 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 → 49502-0627-62. 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.

Clinical

📖 What it is MedlinePlus · NLM

Estrogen and progestin transdermal (patch) contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (levonorgestrel or norelgestromin) are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries) and by changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of human immunodeficiency virus (HIV; the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transm...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You wear one patch a week for 3 weeks, always changing it on the same day. Week 4 is patch-free, and you can expect a withdrawal bleed. Then you start a new patch the next day. Nev...
  • How do I use the birth control patch each month?
  • You can place it on your upper outer arm, abdomen, buttock or back. Do not put it on your breasts. Don't cut or alter it, because that may make it less effective.
  • Where can I put the patch, and can I cut it?
📖 Read our full Ethinyl Estradiol / Norelgestromin 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
49502-0627-62 You're viewing this Main listing 3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 7 d in 1 PATCH 2026-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gwyn Lo 220 ug/d; 20 ug/dthis 49502-0627-62 Viatris 3 patches — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2026
First FDA approval
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 28, 2026 RLD RS ⏳ ~2.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity NP
2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJul 28, 2029
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🧪 Avoiding an ingredient? See Ethinyl Estradiol / Norelgestromin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerViatris Specialty LLC
Application holderVIATRIS SPECIALITY LLC
FDA applicationNDA219990 (NDA)
Labeler code49502
First marketedOct 2026
Product typeHuman Prescription Drug
Portfolio122 products on file

More NDCs from Viatris Specialty LLC labeler code 49502

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 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 KG/M 2 Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including GWYN LO, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ] .

Contraindicated in Women with a BMI ≥ 30 kg/m 2 GWYN LO is contraindicated in women with a BMI ≥ 30 kg/m 2 . The risk of VTE may be greater with GWYN LO in women with a BMI > 30 kg/m 2 compared to women with a lower BMI [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 KG/M 2 See full prescribing information for complete boxed warning. • GWYN LO is contraindicated in women over 35 years old who smoke.

Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptives (CHC) use. ( 4 , 5.1 ) • GWYN LO is contraindicated for use in women with a BMI ≥ 30 kg/m 2 . Women with a BMI ≥ 30 kg/m 2 who use transdermal combined hormonal contraceptives may have a higher risk of venous thromboembolic events compared with women with a lower BMI.

( 4 , 5.1 , 8.7 )

🎯 Indications and Usage 68 words ▾

1 INDICATIONS AND USAGE GWYN LO is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. GWYN LO is a progestin/estrogen combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • GWYN LO uses a 28-day (4-week) cycle. Apply a new TDS to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is TDS-free. ( 2.2 , 2.4 ) • Apply each new TDS on the same day of the week. Wear only one TDS at a time. ( 2.2 ) • Do not cut or alter the TDS in any way. ( 2.2 )

2.1Important Dosage and Administration Information • GWYN LO is for transdermal use only. • For patients switching between combination hormonal contraceptives, products may not be comparable on a microgram-per-microgram basis when evaluating the dosage and strength. • Conclusions on GWYN LO’s effectiveness and safety should not be based solely on dosage and strength [see Dosage Forms and Strengths (3) , Adverse Reactions (6) , and Clinical Studies (14) ].

2.2Recommended Dosage and Administration The GWYN LO transdermal system (TDS) is used in a 28-day (4-week) cycle. The GWYN LO dosage is norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day. A new TDS is applied each week for 3 weeks (21 total days).

Week 4 is TDS-free. Withdrawal bleeding is expected during this time. Apply every new TDS on the same day of the week.

This day is known as the “Patch Change Day.” For example, if the first TDS is applied on a Monday, all subsequent TDS should be applied on a Monday. Only one TDS should be worn at a time. Do not cut, damage or alter the GWYN LO TDS in any way.

If the GWYN LO TDS is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week 4 ends, a new 4-week cycle is started by applying a new TDS. Under no circumstances should there be more than a 7-day TDS-free interval between dosing cycles.

2.3How to Start Using GWYN LO There are multiple options for starting GWYN LO, and the woman should choose the option that is most appropriate (see Table 1): Table 1: Dosage and Administration Instructions for Starting GWYN LO Starting GWYN LO in women with no current use of hormonal contraception Day 1 Start • Apply the TDS during the first 24 hours of her menstrual period. If a TDS is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only. • Apply a new TDS each week for three weeks (21 total days).

Apply the new TDS on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first TDS is applied on a Monday, apply all subsequent transdermal systems on a Monday. Only one TDS should be worn at a time. • No TDS is worn during Week Four (the “Patch-Free Week”).

Withdrawal bleeding is expected during this time. • On the day after Week 4 ends, start a new 4-week cycle by applying a new TDS. Under no circumstances should there be more than a 7-day TDS-free interval between dosing cycles. Sunday Start • Apply the TDS after the onset of menses. • A non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. • If the onset of menses is on a Sunday, apply the first TDS on that day, and no backup contraception is needed.

Starting GWYN LO in women switching from another hormonal contraceptive method or non-hormonal intrauterine systems Oral combination hormonal contraception (oral CHC) • Apply the first GWYN LO TDS on the day when the new pack would have been started. • If menses does not begin within a week after taking the last active pill, instruct the woman to consult with a healthcare professional to be sure that pregnancy has not occurred. If no pregnancy has occurred, start GWYN LO. • If GWYN LO is applied more than a week after taking the last active pill, use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of TDS use.

Transdermal system • Apply the first GWYN LO TDS on the day the next transdermal… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Transdermal System: 220 mcg/day norelgestromin (NGMN) and 20 mcg/day ethinyl estradiol (EE), 14 cm² tan colored product with name and strength printed in brown ink on the backing membrane. Transdermal system: 220 mcg/day norelgestromin and 20 mcg/day ethinyl estradiol. ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS GWYN LO is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thromboembolic events. Examples include women who: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] o Have inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions (5.4) ] o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] o Have headaches with focal neurological symptoms or have migraine headaches with aura or women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] • Body Mass Index ≥ 30 kg/m 2 [see Boxed Warning , Warnings and Precautions (5.1) , and Use in Specific Populations (8.7) ] • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.10) ] • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, due to the potential for alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.3) ] • High risk of arterial or venous thromboembolic events.

( 4 ) • BMI ≥ 30 kg/m 2 . ( 4 ) • Liver tumors, acute viral hepatitis or decompensated cirrhosis. ( 4 ) • Undiagnosed abnormal uterine bleeding.

( 4 ) • Breast cancer or other estrogen- or progestin-sensitive cancer. ( 4 ) • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Vascular Risks: Stop GWYN LO 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 women, particularly those over 35 years. ( 5.1 ) • Liver Disease: Discontinue GWYN LO if jaundice occurs. ( 5.2 ) • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C .

( 5.3 ) • Hypertension: If used in women with well-controlled hypertension, monitor blood pressure and stop use if blood pressure rises significantly. ( 5.4 ) • Gallbladder Disease: May cause or worsen gallbladder disease. ( 5.5 ) • Adverse Carbohydrate and Lipid Metabolic Effects: Monitor glucose in prediabetic and diabetic women taking GWYN LO.

Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) • Headache: Evaluate significant change in headaches and discontinue GWYN LO if indicated. ( 5.7 ) • Uterine Bleeding: May cause irregular bleeding or amenorrhea.

Evaluate for other causes if symptoms persist. ( 5.8 )

5.1Thromboembolic Disorders and Other Vascular Conditions • Stop GWYN LO if an arterial or venous thromboembolic event (VTE) occurs. • Stop GWYN LO if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. • If feasible, stop GWYN LO at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of GWYN LO during prolonged immobilization and resume treatment based on clinical judgment. • Start GWYN LO no earlier than 4 weeks after delivery, in women who are not breastfeeding.

The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. • Before starting GWYN LO, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy [see Contraindications (4) ] . Arterial Events The use of CHCs increases 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 women with hypertension, dyslipidemia, diabetes, or obesity. GWYN LO is contraindicated in women over 35 years of age who smoke [see Contraindications (4) ] . Cigarette smoking increases the risk of serious cardiovascular events from CHC use.

This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events GWYN LO is contraindicated in women with a BMI ≥ 30 kg/m 2 . The use of CHCs 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 CHCs. The risk of VTE may be greater with transdermal CHCs in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications (4) ]. While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1).

The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. This initial higher risk declines during the first year, but users of CHCs remain at an increased risk of VTE compared to non-users of CHCs.

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 CHCs gradu… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions with the use of combination hormonal contraceptives, including GWYN LO, are discussed elsewhere in the labeling: • Serious cardiovascular events including venous and arterial thromboembolism [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.1) ] • Liver Disease [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 2%) in clinical trials for GWYN LO were application site irritation, application site erythema, application site pruritus, intercycle and heavy withdrawal bleeding, and nausea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of GWYN LO was evaluated in a 12-month, multicenter, open-label, single-arm clinical trial conducted in the United States [see Clinical Studies (14) ]. The safety population included 1,272 sexually active women who received 13 cycles of GWYN LO.

The women ranged in age from 16-54 years (mean 27.8 years) and were predominantly white (67.2%). The mean BMI of the safety population was 25.6 kg/m 2 . Discontinuation due to an adverse reaction occurred in 7.2% of women.

The most common adverse reaction (≥ 1%) leading to discontinuation was application site irritation (1.2%). The most common adverse reactions (≥ 2%) reported during the clinical trial were application site irritation, application site erythema, application site pruritus, intercycle and heavy withdrawal bleeding, and nausea. Adverse reactions reported by ≥ 2% of GWYN LO-treated women in the trial are shown in Table 2.

Table 2: Adverse Reactions Reported by ≥ 2% of GWYN LO-Treated Women in Study 1 Adverse Reaction GWYN LO (n = 1,272) General disorders and administration site conditions Application site irritation 4.8% Application site erythema 3.7% Application site pruritus 3.7% Reproductive system and breast disorders Intercycle bleeding 3.9% Heavy withdrawal bleeding 2.0% Gastrointestinal disorders Nausea 2.0% Venous Thromboembolism (VTE) During Study 1, one thromboembolic event (pulmonary embolism), syncope, and seizure were reported in a female who had been using GWYN LO for 42 days and had a BMI of 27.6 kg/m 2 .

Other Serious Adverse Reactions This serious adverse reaction occurred in < 1% of women who received GWYN LO: suicidal ideation in three women with psychiatric histories, one of whom also experienced exacerbation of depression.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Enzymes inducers (e.g., CYP3A4): May decrease the effectiveness of GWYN LO or increase breakthrough bleeding. Counsel women to use a back-up or alternative method of contraception when enzyme inducers are used with GWYN LO. ( 7.1 )

7.1Effects of Other Drugs on Combined Hormonal Contraceptives Substances Decreasing the Plasma Concentrations of CHCs and Potentially Diminishing the Efficacy of CHCs Table 3 includes substances that demonstrated an important drug interaction with GWYN LO. Table 3: Significant Drug Interactions Involving Substances That Affect CHCs Metabolic Enzyme Inducers Clinical effect • Concomitant use of CHCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of CHCs . • Decreased exposure of the estrogen and/or progestin component of CHCs may potentially diminish the effectiveness of CHCs and may lead to contraceptive failure or an increase in breakthrough bleeding.

Prevention or management • Counsel women to use an alternative method of contraception or a backup method when enzyme inducers are used with CHCs. • Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort, Induction potency of St.

John’s wort may vary widely based on preparation. and certain protease inhibitors (see separate section on protease inhibitors below). Colesevelam Clinical effect • Concomitant use of CHCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. • Decreased exposure of the estrogen component of CHCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the CHC. Prevention or management • Administer 4 or more hours apart to attenuate this drug interaction.

Substances Increasing the Plasma Concentrations of CHCs: Co-administration of atorvastatin or rosuvastatin and CHCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of CHCs.

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 CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).

In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).

7.2Effects of Combined Hormonal Contraceptives on Other Drugs Table 4 provides significant drug interaction information for drugs co-administered with GWYN LO. Table 4: Significant Drug Interaction Information for Drugs Co-Administered with CHCs Lamotrigine Clinical effect • Concomitant use of CHCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation. • Decreased systemic exposure of lamotrigine may reduce seizure control. Prevention or management Dose adjustment may be ne… [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 method; GWYN LO can decrease milk production. ( 8.2 )

8.1Pregnancy Risk Summary Discontinue GWYN LO if pregnancy occurs. There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 CHCs 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% and 15 to 20%, respectively.

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

When possible, advise the nursing woman to use other methods of contraception until she discontinues breastfeeding [see Dosage and Administration (2.3) ] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GWYN LO and any potential adverse effects on the breast-fed child from GWYN LO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of GWYN LO have been established in females of reproductive potential with a BMI < 30 kg/m 2 to prevent pregnancy. Efficacy is expected to be the same for postmenarcheal females younger than 17 years of age as for those 17 years of age and older. Use of GWYN LO before menarche is not indicated.

8.5Geriatric Use GWYN LO has not been studied in postmenopausal women and is not indicated in this population.

8.6Hepatic Impairment No studies with GWYN LO have been conducted in women with hepatic impairment. However, steroid hormones may be poorly metabolized in women with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.2) ] .

8.7BMI and Weight Considerations GWYN LO is contraindicated in women with a BMI ≥ 30 kg/m 2 because of the potential increased risk of VTE [see Contraindications (4) and Warnings and Precautions (5.1) ]. The safety and effectiveness of GWYN LO in females with a BMI ≥ 30 kg/m 2 has not been fully evaluated [see Clinical Studies (14) ] .

🤰 Pregnancy 90 words ▾

8.1Pregnancy Risk Summary Discontinue GWYN LO if pregnancy occurs. There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 CHCs 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% and 15 to 20%, respectively.

🧒 Pediatric Use 62 words ▾

8.4Pediatric Use The safety and effectiveness of GWYN LO have been established in females of reproductive potential with a BMI < 30 kg/m 2 to prevent pregnancy. Efficacy is expected to be the same for postmenarcheal females younger than 17 years of age as for those 17 years of age and older. Use of GWYN LO before menarche is not indicated.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use GWYN LO has not been studied in postmenopausal women and is not indicated in this population.

🆘 Overdosage 30 words ▾

10 OVERDOSAGE Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, remove all GWYN LO transdermal systems and provide symptomatic treatment.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Combination hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.

12.2Pharmacodynamics No pharmacodynamic study with GWYN LO has been conducted. One clinical trial of a transdermal system with norelgestromin and ethinyl estradiol assessed the return of hypothalamic-pituitary-ovarian axis function post-therapy and found that follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol mean values, though suppressed during therapy, returned to near baseline values during the 6 weeks post-therapy.

12.3Pharmacokinetics The pharmacokinetics of norelgestromin and ethinyl estradiol following a single application of GWYN LO were characterized in healthy women. Pharmacokinetic parameters are presented in Table 5. Table 5: Arithmetic Mean (%CV) Norelgestromin and Ethinyl Estradiol Pharmacokinetic Parameters in Healthy Women Following a Single Transdermal Application of GWYN LO on the Lower Abdomen No clinically meaningful differences in the systemic exposures of norelgestromin and ethinyl estradiol were observed when GWYN LO was applied on the lower abdomen, upper outer arm, buttock, or upper back.

GWYN LO Parameter Norelgestromin (n=28) Ethinyl Estradiol (n=28) AUC 0- ∞ (pg*hr/mL) 166331.0 (27.8%) 4203.2 (60.7%) AUC 0-264hr (pg*hr/mL) 162315.6 (27.6%) 3806.8 (33.7%) C max (pg/mL) 1029.4 (27.5%) 28.39 (33.7%) Absorption Following a single application of GWYN LO in healthy women, both norelgestromin and ethinyl estradiol reach peak by approximately 90 hours. Effect of Sauna, Whirlpool, Treadmill and Cold-water Bath Following application of GWYN LO under conditions encountered in a health club (sauna, whirlpool and treadmill) and in a cold-water bath, there were no significant treatment effects on C max or AUC of norelgestromin and ethinyl estradiol when compared to normal wear.

Distribution Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins. Norelgestromin is bound to albumin and not to sex hormone-binding globulin (SHBG), while norgestrel is bound primarily to SHBG, which limits its biological activity. Ethinyl estradiol is extensively bound to serum albumin and induces an increase in the serum concentrations of SHBG.

Elimination Norelgestromin estimated elimination half-life is ~30 hours. Ethinyl estradiol estimated elimination half-life is ~24 hours. Metabolism Norelgestromin undergoes hepatic metabolism, producing metabolites that include norgestrel and various hydroxylated and conjugated metabolites.

Ethinyl estradiol is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates. Excretion The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action Combination hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.

📦 How Supplied / Storage and Handling 154 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied GWYN LO (norelgestromin and ethinyl estradiol transdermal system) is a 14 cm 2 tan colored product with “Gwyn Lo™ (norelgestromin and ethinyl estradiol) 220 mcg/20 mcg per day” printed in brown ink and is supplied as: • A carton of 3 identical TDS, each TDS packaged in a protective pouch. NDC 49502-627-62 • A single TDS provided for replacement as needed. NDC 49502-627-65

16.2Special Precautions for Storage and Disposal Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Store in original unopened pouch. Do not store in the refrigerator or freezer. Used TDS still contain some active hormones.

To discard, fold the sticky sides of the TDS together, place in a sturdy container, preferably with a child-resistant cap, and place this container in the trash. Do not discard used TDS in the toilet.

📋 Description 217 words ▾

11 DESCRIPTION GWYN LO (norelgestromin and ethinyl estradiol transdermal system) contains 4.86 mg norelgestromin, USP, a progestin, and 0.264 mg ethinyl estradiol, USP, an estrogen. GWYN LO is a transdermal system (TDS) designed to provide consistent delivery of norelgestromin and ethinyl estradiol over a 7-day wear period. Based on residual drug analysis from TDS used in clinical studies, GWYN LO is expressed as 220 mcg/day norelgestromin and 20 mcg/day ethinyl estradiol.

GWYN LO is a thin, matrix-type transdermal system consisting of three layers. The backing layer is printed with brown ink and is composed of a tan flexible film consisting of a pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment.

The middle layer contains the norelgestromin and ethinyl estradiol and the following inactive ingredients crospovidone, dipropylene glycol, mineral oil, nonwoven polyester fabric, oleyl alcohol, and polyisobutylene adhesive. The third layer is a transparent release coated polyester liner, which protects the adhesive layer during storage and is removed just prior to application. GWYN LO transdermal systems are packaged with additional pieces of oversized protective film above and below the system within each pouch.

These pieces of oversized protective film are removed and discarded at the time of use. Norelgestromin and Ethinyl Estradiol Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the woman to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Cigarette Smoking Advise the woman that cigarette smoking increases the risk of serious cardiovascular events from CHC use. Women who are over 35 years old and smoke should not use GWYN LO [see Boxed Warning and Warnings and Precautions (5.1) ] .

Venous Thromboembolism Advise the woman that there is an increased risk of VTE compared to non-users of CHCs which is greatest after initially starting a CHC or restarting (following a 4-week or greater interruption in intake) the same or a different CHC [see Warnings and Precautions (5.1) ] . Use During Pregnancy Instruct the woman to stop GWYN LO if pregnancy is confirmed during treatment [see Use in Specific Populations (8.1) ] . Sexually Transmitted Infections Advise the woman that GWYN LO does not protect against HIV infection and other sexually transmitted infections.

Missed Dosing Instructions Apply one GWYN LO TDS weekly for 3 weeks followed by one TDS-free week. Instruct women what to do in the event the TDS change is missed. See the FDA-approved patient labeling ( Instructions for Use ) [see Dosage and Administration (2.4) ] .

Need for Additional Contraception Advise postpartum women who have not yet had a period when they start GWYN LO to use an additional method of contraception until they have used GWYN LO for one week [see Dosage and Administration (2.2) ] . Advise the woman to use a back-up or alternative method of contraception when enzyme inducers are used with GWYN LO [see Drug Interactions (7.1) ] . Lactation GWYN LO may reduce breast milk production.

This is less likely to occur if breastfeeding is well established. When possible, advise nursing women to 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.

Advise the woman to contact a healthcare provider in the event of amenorrhea in two or more consecutive cycles or in case of symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.8) ] . Avoidance of GWYN LO Detachment Advise women not to use lotions, creams, oils, powders, or make-up at the TDS site and to check the GWYN LO TDS for partial or complete detachment not only daily but also after any water exposure (for example, bathing or showering) to make sure all edges are sticking correctly [see Dosage and Administration (2.4) ] .

Keep GWYN LO and all medicines out of reach of children and pets. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2026 Viatris Inc. Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company.

VSL:NEETSLO222:R1

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The pharmacokinetics of norelgestromin and ethinyl estradiol following a single application of GWYN LO were characterized in healthy women. Pharmacokinetic parameters are presented in Table 5. Table 5: Arithmetic Mean (%CV) Norelgestromin and Ethinyl Estradiol Pharmacokinetic Parameters in Healthy Women Following a Single Transdermal Application of GWYN LO on the Lower Abdomen No clinically meaningful differences in the systemic exposures of norelgestromin and ethinyl estradiol were observed when GWYN LO was applied on the lower abdomen, upper outer arm, buttock, or upper back.

GWYN LO Parameter Norelgestromin (n=28) Ethinyl Estradiol (n=28) AUC 0- ∞ (pg*hr/mL) 166331.0 (27.8%) 4203.2 (60.7%) AUC 0-264hr (pg*hr/mL) 162315.6 (27.6%) 3806.8 (33.7%) C max (pg/mL) 1029.4 (27.5%) 28.39 (33.7%) Absorption Following a single application of GWYN LO in healthy women, both norelgestromin and ethinyl estradiol reach peak by approximately 90 hours. Effect of Sauna, Whirlpool, Treadmill and Cold-water Bath Following application of GWYN LO under conditions encountered in a health club (sauna, whirlpool and treadmill) and in a cold-water bath, there were no significant treatment effects on C max or AUC of norelgestromin and ethinyl estradiol when compared to normal wear.

Distribution Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins. Norelgestromin is bound to albumin and not to sex hormone-binding globulin (SHBG), while norgestrel is bound primarily to SHBG, which limits its biological activity. Ethinyl estradiol is extensively bound to serum albumin and induces an increase in the serum concentrations of SHBG.

Elimination Norelgestromin estimated elimination half-life is ~30 hours. Ethinyl estradiol estimated elimination half-life is ~24 hours. Metabolism Norelgestromin undergoes hepatic metabolism, producing metabolites that include norgestrel and various hydroxylated and conjugated metabolites.

Ethinyl estradiol is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates. Excretion The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways.

🧬 Pharmacodynamics 58 words ▾

12.2Pharmacodynamics No pharmacodynamic study with GWYN LO has been conducted. One clinical trial of a transdermal system with norelgestromin and ethinyl estradiol assessed the return of hypothalamic-pituitary-ovarian axis function post-therapy and found that follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol mean values, though suppressed during therapy, returned to near baseline values during the 6 weeks post-therapy.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of GWYN LO was evaluated in Study 1, a Phase 3, open label, single arm, multicenter trial in the United States, and Canada (NCT05139121) of one-year duration that enrolled 1,320 women, ranging in age between 16 and 54 years, who were healthy and sexually active with regular menstrual cycles. The primary efficacy analysis population included 983 women between the ages of 16 and 35 years with BMI < 30 kg/m 2 , who completed 9,105 evaluable cycles with GWYN LO, where no back-up contraception was used, and sexual intercourse occurred.

The mean age was 26.4 years (range: 16 to 35) with an average baseline BMI of 24 kg/m 2 (range: 15 to 30 kg/m 2 ). The racial/ethnic distribution was Whites (68.9%), Black/African Americans (18.7%), Asians (7.5%), American Indians/Alaskan Natives (1.1%), Native Hawaiian/Pacific or Other Pacific Islander (0.3%), and Other (3.5%); 45.5% were Hispanics. The primary efficacy endpoint was the Pearl Index (PI), defined as the number of pregnancies per 100-woman years of exposure.

The overall PI was 4.14 (95% CI: 2.77 to 5.95). There were no differences in efficacy by BMI Category as shown in Table 6 below. Table 6: Pearl Index Efficacy Analysis by BMI Subgroup in Women Aged ≤ 35 Years with BMI < 30 kg/m² BMI (kg/m 2 ) Number of Evaluable Cycles Pearl Index (95% CI) < 25 4936 4.48 (2.61-7.17) ≥ 25 to < 30 4169 3.74 (1.93-6.54) Overall 9105 4.14 (2.77-5.95) Adhesion Based on data from four studies investigating various application sites and conditions (e.g., sauna, whirlpool and treadmill), a total of 323 out of 342 (94.44%) applied systems had 75% or greater surface area adhesion at all timepoints evaluated (every 24 hours) throughout the 7-day wear period.

In Study 1, 1.3% of all transdermal systems worn during the year-long trial (39,790 transdermal systems) fully detached. No notable differences in subject reported adhesion score were found based on application sites.

🧪 Nonclinical Toxicology 64 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility See Warnings and Precautions (5.2 , 5.10) and Use in Specific Populations (8.1) . Norelgestromin was tested in in vitro mutagenicity assays (bacterial plate incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay using cultured human peripheral lymphocytes) and in one in vivo test (rat micronucleus assay) and found to have no genotoxic potential.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 61 words ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility See Warnings and Precautions (5.2 , 5.10) and Use in Specific Populations (8.1) . Norelgestromin was tested in in vitro mutagenicity assays (bacterial plate incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay using cultured human peripheral lymphocytes) and in one in vivo test (rat micronucleus assay) and found to have no genotoxic potential.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION GWYN LO TM [GWEN-low] (norelgestromin and ethinyl estradiol transdermal system) What is the most important information I should know about GWYN LO? • Do not use GWYN LO if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. • Do not use GWYN LO if your Body Mass Index (BMI) is 30 kg/m 2 or more.

Women with a BMI of 30 kg/m 2 or more who use GWYN LO may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m 2 . Hormonal birth control methods help to lower the chances of becoming pregnant when taken as directed. GWYN LO does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

What is GWYN LO? GWYN LO is: • a birth control patch for women with a BMI less than 30 kg/m 2 who can become pregnant. It contains two female hormones, a progestin called norelgestromin, and an estrogen called ethinyl estradiol.

How well does GWYN LO work? Your chance of getting pregnant depends on how well you follow the directions for using GWYN LO. The better you follow the directions, the less chance you have of getting pregnant.

In a clinical study, 4 out of 100 women got pregnant in one year that they used GWYN LO. For GWYN LO to be most effective, you must use GWYN LO exactly as your healthcare provider tells you to. Each patch must be fully attached to the skin during the 7 days in order for it to work the best.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart.

The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Do not use GWYN LO if you: • smoke and are over 35 years old. • have or have had blood clots in your arms, legs, eyes or lungs. • have had a stroke. • have had a heart attack. • have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart. • have a problem that makes your blood clot more than normal that you were born with (inherited) or that has happened for other reasons such as medicines, surgery or injuries (acquired). • have high blood pressure that is not controlled. • have diabetes with kidney, eye, nerve, or blood vessel damage. • have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35. • have a BMI of 30 or more. • have liver problems including liver tumors, hepatitis, cirrhosis, or liver disease. • have unexplained vaginal bleeding. • have or have had breast cancer or any cancer that is sensitive to female hormones. • take any Hepatitis C drug combination-containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, or with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir.

This may increase levels of the liver enzyme called alanine aminotransferase (ALT) in the blood. GWYN LO may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes). Tell your healthcare provider if you have ever had any of the above conditions.

Your healthcare provider may recommend another method of birth control. Before using GWYN LO, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or think you are pregnant. GWYN LO is not for pregnant women.

If you think you are pregnant, you should have a pregnancy test and know the results. Do not use GWYN LO if the test is positive and talk to your healthcare provider. • are scheduled for surgery. GWYN LO may increase yo… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE GWYN LO™ [GWEN-low] (norelgestromin and ethinyl estradiol transdermal system) This Instructions for Use contains information on how to use GWYN LO transdermal system (TDS) (also called a patch). Important Information You Need to Know Before Using GWYN LO • Each patch is individually sealed in a pouch. Do not remove the patch from the pouch until you are ready to apply it. • GWYN LO is for skin use only. • Do not share your GWYN LO patch with any other person. • Do not cut, damage or alter your GWYN LO patch in any way. • Wear the patch for 7 Days (1 week) and then apply a new patch.

If the patch is cut, damaged or changed in any way, it may be less effective. • Apply a new patch on the same day each week (Patch Change Day) for 3 weeks (Weeks 1 to 3). • Remove the old GWYN LO patch before applying a new one. • During Week 4, do not wear a patch. • After Week 4, repeat the cycle of 3 weeks of applying a patch followed by a patch free week. • The patch must stick securely to your skin to work properly. • Do not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. • Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing. • If you are not sure how to use your patch: o Use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex.

Make sure to have one of these non-hormonal contraception methods ready at all times. Preparing to use GWYN LO • If you are not currently using hormonal birth control, you have 2 ways to begin using your GWYN LO patch. Choose the way that is best for you: o Day 1 Start: Apply your first GWYN LO patch during the first 24 hours of your menstrual period.

Your “Patch Change Day” will be on this day every week. If you start after the first 24 hours of your menstrual period, non-hormonal back up birth control (such as condoms and spermicide, or diaphragm and spermicide) should be used in addition to the patch for the first 7 days of your first patch cycle. o Sunday Start: Apply your first GWYN LO patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only.

If your period starts on Sunday, apply your first GWYN LO patch that day, and no back-up birth control is needed. • If you are changing from oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive patch to the GWYN LO patch: o Complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. Apply your first GWYN LO patch on the day you would normally start your next oral hormone birth control pill, patch or insert your next vaginal ring. o If you do not get your period within 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant.

You may still go ahead and start GWYN LO patch for contraception. o If you apply your GWYN LO patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide with the GWYN LO patch for the first 7 days of patch use. • If you are using GWYN LO after childbirth: o If you are not breastfeeding, wait 4 weeks before using GWYN LO and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only.

If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before st… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – 220 mcg/20 mcg NDC 49502-627-62 Contents: 3 Transdermal Systems | Rx only Gwyn Lo ™ (norelgestromin and ethinyl estradiol transdermal system) 220 mcg/20 mcg per day Each 14 cm 2 system contains 4.86 mg norelgestromin, USP and 0.264 mg ethinyl estradiol, USP. The inactive components are crospovidone, dipropylene glycol, mineral oil, nonwoven polyester fabric, oleyl alcohol, polyethylene/polyester film, polyisobutylene adhesive and release coated polyester liner. Each patch is printed with brown ink.

This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. For Transdermal Use Only Dosage: see Prescribing Information.

Apply immediately upon removal from pouch. Each transdermal system is intended to be worn 7 days as prescribed. Keep out of reach of children.

Package not child-resistant. Store in the pouch until ready for use. Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Do not store in the refrigerator or freezer.

See Patient Information and Instructions for Use. Note your Patch Change Day here Sunday Monday Tuesday Wednesday Thursday Friday Saturday To discard: 1) fold the sticky sides together, 2) place in sturdy child-proof container, and 3) place in the trash. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A.

Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2026 Viatris Inc. VSL:627:222:3C:R1 Gwyn Lo 220 mcg/20 mcg Container Label

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

About this NDC listing & data coverage

Finished prescription product
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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 Viatris Specialty LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Viatris Specialty LLC 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.
← 49502-0605-05 · Viatris 49502-0806-87 · Viatris →
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.