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Estarylla Norgestimate and ethinyl estradiol Kit — NDC 70700-119-85 (Billing 70700-0119-85)

by Xiromed, LLC. · 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

This is a package of Estarylla Norgestimate and ethinyl estradiol Kit from Xiromed, LLC., marketed since Jan 2018 and currently FDA-listed; retail pharmacies pay about $0.1148 per unit (NADAC). It is this product's only package size.

NDC 70700-0119-85
🏷️ FDA NDC (as labeled) 70700-119-85 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Norgestimate And Ethinyl Estradiol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 2, 2025 — Failed Content Uniformity Specifications (AvKARE) · FDA recall D-0007-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70700-119-85
Product NDC 70700-119
11-digit billing NDC 70700011985
NCPDP billing unit EA — each (per item)
RxCUI 240128, 748797, 749860, 1369737
Application # ANDA090794
SPL Set ID 7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f8
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-01
Dosage form KIT
TE code (Orange Book) AB · RLD · RS

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

GPI-14 25990002950310
GPI class Estarylla
GCN Seq No 013662
GCN 11300
HICL code 004845
Ingredient (HICL) Norgestimate-Ethinyl 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 ESTARYLLA 0.25-0.035 MG TABLET
FDB brand name Estarylla
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013662
  • GCN: 11300
  • GPI-14 (Medi-Span): 25990002950310
  • HICL (First Databank): 004845
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 240128
Why two NDCs? The FDA registers this code as 70700-119-85 — 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 → 70700-0119-85. 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 Progestin class.

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

Clinical

Label name ESTARYLLA 0.25-0.035 MG TABLET Ingredient Norgestimate-Ethinyl Estradiol

Supplement & herbal interactions

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

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.115 $0.34 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.2815 $0.84 / 3 kit
Medicare drug plans payPart D · Q2 2026 $0.2479 $0.74 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.182 $0.115
▼ Down 37% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70700-0119-85 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2018-03-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tri-Lo-Sprintec 00093-2140-62 Teva 3 pouches $0.108 AB Availability likely save 6%
Tri-Lo-Mili 65862-0778-28 Aurobindo 1 kit $0.108 AB Availability likely save 6%
Tri-VyLibra Lo 50102-0231-13 Afaxys 1 kit $0.108 AB Availability likely save 6%
Tri-Lo- Estarylla 70700-0120-85 Xiromed, 1 kit $0.108 AB Availability likely save 6%
Tri-Lo-Marzia 68180-0837-73 Lupin 3 pouches $0.108 AB Availability likely save 6%
Estaryllathis 70700-0119-85 Xiromed, 1 kit $0.115 AB Availability likely —
Sprintec 00555-9016-58 Teva 6 pouches $0.115 AB Availability likely —
VyLibra 50102-0235-11 Afaxys 1 kit $0.115 AB Availability likely —
Mono-Linyah 16714-0360-01 Northstar 1 packet $0.115 AB Availability likely —
Mili 65862-0776-28 Aurobindo 1 kit $0.115 AB Availability likely —
Norgestimate and Ethinyl Estradiol 68462-0309-29 Glenmark 1 kit $0.115 AB Availability likely —
Norgestimate and Ethinyl Estradiol 68180-0840-73 Lupin 3 pouches $0.115 AB Availability likely —
Tri-Mili 65862-0777-28 Aurobindo 1 kit $0.126 AB Availability likely +10%
Tri-Estarylla 70700-0121-85 Xiromed, 1 kit $0.126 AB Availability likely +10%
Norgestimate and Ethinyl Estradiol 68462-0565-29 Glenmark 1 kit $0.126 AB Availability likely +10%
Tri-Sprintec 00555-9018-58 Teva 6 pouches $0.126 AB Availability likely +10%
Norgestimate and ethinyl estradiol 68180-0838-73 Lupin 1 kit $0.126 AB Availability likely +10%
Tri-VyLibra 50102-0233-11 Afaxys 1 kit $0.126 AB Availability likely +10%
Tri-Linyah 16714-0363-01 Northstar 1 packet $0.126 AB Availability likely +10%
Nymyo 51862-0645-01 Mayne 1 packet $0.135 AB FDA listed +17%
Tri-Nymyo 51862-0646-01 Mayne 1 packet $0.140 AB FDA listed +22%
Tri Femynor 69238-1607-06 Amneal 1 kit $0.140 — FDA listed +22%
Femynor 69238-1551-06 Amneal 1 kit $0.144 — FDA listed +26%
Tri-Sprintec 63187-0458-28 Proficient 6 pouches — AB FDA listed —
Tri-Lo-Marzia 63187-0754-28 Proficient 1 pouch — AB FDA listed —
Sprintec 63187-0911-28 Proficient 1 pouch — AB FDA listed —
Norgestimate and Ethinyl Estradiol 71205-0191-28 Proficient 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 42291-0553-84 AvKARE 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 42291-0565-84 AvKARE 1 kit — AB FDA listed —
norgestimate and ethinyl estradiol 42291-0590-84 AvKARE 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 50090-2603-00 A-S 1 kit — AB FDA listed —
Tri-Lo-Sprintec 71205-0287-28 Proficient 1 pouch — AB FDA listed —
Tri-Lo-Mili 71205-0746-28 Proficient 1 kit — AB FDA listed —
Norgestimate and ethinyl estradiol 79929-0008-07 Naari 1 kit — AB FDA listed —
Tri-Estarylla 63629-2350-01 Bryant 1 kit — AB FDA listed —
Norgestimate and ethinyl estradiol 79929-0009-07 Naari 1 kit — AB FDA listed —
Estarylla 82804-0158-28 Proficient 1 pouch — AB FDA listed —
Tri-Sprintec 68788-6325-02 Preferred 1 pouch — AB FDA listed —
norgestimate and ethinyl estradiol 72789-0435-79 PD-Rx 1 pouch — AB FDA listed —
Mono-Linyah 50090-4881-00 A-S 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 72789-0434-79 PD-Rx 1 pouch — AB FDA listed —
Tri-Lo-Marzia 50090-2429-00 A-S 1 kit — AB FDA listed —
Estarylla 63629-2349-01 Bryant 1 kit — AB Discontinued —
Sprintec 68788-7429-02 Preferred 1 pouch — AB FDA listed —
Tri-Estarylla 50090-7861-00 A-S 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 50090-2259-00 A-S 1 kit — AB FDA listed —
Tri-Lo- Estarylla 63629-2351-01 Bryant 1 kit — AB FDA listed —
Mono-Linyah 67296-2329-08 Redpharm 1 kit — AB 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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerXiromed, LLC.
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA090794 (ANDA)
Labeler code70700
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio13 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 115 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 are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS (4) ].

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Norgestimate and ethinyl estradiol are contraindicated in women over 35 years old who smoke. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. ( 4 )

🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE Estarylla (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( 1.1 )

1.1Oral Contraceptive Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. ( 2.2 ) • Take tablets in the order directed on the blister pack. ( 2.2 ) • Do not skip or delay tablet intake. ( 2.2 )

2.1How to Start Estarylla? Estarylla (norgestimate and ethinyl estradiol tablets), dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )]. Estarylla may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

2.2How to Take Estarylla? Table 1: Instructions for Administration of Estarylla Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important : Consider the possibility of ovulation and conception prior to initiation of this product.

Tablet Color: • Estarylla active tablets are blue (Day 1 to Day 21). • Estarylla has green inactive tablets (Day 22 to Day 28) Day 1 Start: • Take first active tablet without regard to meals on the first day of menses. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. • Begin each subsequent blister pack on the same day of Estarylla™ the week as the first cycle blister pack (i.e., on the day after taking the last inactive tablet) Sunday Start: • Take first active tablet without regard to meals on the first Sunday after the onset of menses.

Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle blister pack of Estarylla . • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. • Begin each subsequent blister pack on the same day of the week as the first cycle blister pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.

Switching to Estarylla from another oral contraceptive Start on the same day that a new blister pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Estarylla Start Estarylla : • 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 • If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle blister pack. • Implant • On the day of removal Starting Estarylla after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, Estarylla may be started immediately.

An additional method of contraception is not needed if Estarylla is started immediately. • If Estarylla is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle blister pack of Estarylla. Second-trimester • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Estarylla, following the instructions in Table 1 for Day 1 or Sunday start, as desired.

If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle bli… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 96 words ▾

3 DOSAGE FORMS AND STRENGTHS • Estarylla is available in blister cards. Each blister pack contains 28 tablets in the following order: • 21 active tablets are blue, round, debossed with SZ on one side and T4 on the other side. • 7 inert tablets are green, round, debossed with SZ on one side and J1 on the other side. Estarylla (norgestimate and ethinyl estradiol tablets, USP) consists of 28 round tablets in the following order ( 3 ): 21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 7 green tablets (inert)

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Estarylla is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 )] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] • 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)] • Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.4 )] • Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.6 )] • Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS ( 5.7 )] • Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7 )] • Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS ( 5.2 )] • Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS ( 5.8 )] • Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS (5.8) and USE IN SPECIFIC POPULATIONS ( 8.1 )] • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS ( 5.11 )] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS ( 5.3 )] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Thromboembolic Disorders and Other Vascular Problems: Stop norgestimate and ethinyl estradiol if a thrombotic 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.

( 5.1 ) • Liver disease: Discontinue norgestimate and ethinyl estradiol if jaundice occurs. ( 5.2 ) • High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop norgestimate and ethinyl estradiol if blood pressure rises significantly. ( 5.4 ) • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking norgestimate and ethinyl estradiol.

Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) • Headache: Evaluate significant change in headaches and discontinue norgestimate and ethinyl estradiol if indicated. ( 5.7 ) • Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea.

( 5.8 )

5.1Thromboembolic Disorders and Other Vascular Problems • Stop norgestimate and ethinyl estradiol if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. • Stop norgestimate and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see ADVERSE REACTIONS (6.2) ]. • If feasible, stop norgestimate and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. • Start norgestimate and ethinyl estradiol 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. • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years.

The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. • Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes).

This risk increases with age, particularly in women over 35 years of age who smoke. • Use COCs with caution in women with cardiovascular disease risk factors.

5.2Liver Disease Impaired Liver Function Do not use norgestimate and ethinyl estradiol in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see CONTRAINDICATIONS (4) ]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue norgestimate and ethinyl estradiol if jaundice develops.

Liver Tumors Norgestimate and ethinyl estradiol is contraindicated in women with benign and malignant liver tumors [see CONTRAINDICATIONS (4) ] . Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users.

Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

5.3Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that c… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: • Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1) ] • Vascular events [see WARNINGS AND PRECAUTIONS (5.1) ] • Liver disease [see WARNINGS AND PRECAUTIONS (5.2) ] Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 1-844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of norgestimate and ethinyl estradiol was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception.

Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles. Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%).

Adverse Reactions Leading to Study Discontinuation: Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5%), headache (4.1%), mood disorders (including depression and mood altered) (2.4%), premenstrual syndrome (1.7%), hypertension (1.4%), breast pain (1.4%), nervousness (1.3%), amenorrhea (1.1%), dysmenorrhea (1.1%), weight increased (1.1%), and flatulence (1.1%).

Serious Adverse Reactions: breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).

6.2Postmarketing Experience 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 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.

The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with norgestimate and ethinyl estradiol. Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding.

Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 )

7.1Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St.

John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Colesevelam : Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%.

Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

7.2Effects of Combined Oral Contraceptives on Other Drugs • COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. • COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation.

This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs.

7.3Interference with Laboratory Tests The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

7.4Concomitant Use with HCV… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing mothers: Not recommended; can decrease milk production. ( 8.3 )

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs 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 low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

Do not use COCs during pregnancy to treat threatened or habitual abortion.

8.3Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

8.4Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

8.5Geriatric Use Norgestimate and ethinyl estradiol have not been studied in postmenopausal women and are not indicated in this population.

8.6Hepatic Impairment The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [See CONTRAINDICATIONS ( 4 ) and WARNINGS AND PRECAUTIONS ( 5.2 ).]

8.7Renal Impairment The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in women with renal impairment.

🤰 Pregnancy 82 words ▾

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs 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 low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

Do not use COCs during pregnancy to treat threatened or habitual abortion.

🧒 Pediatric Use 51 words ▾

8.4Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

🧓 Geriatric Use 21 words ▾

8.5Geriatric Use Norgestimate and ethinyl estradiol have not been studied in postmenopausal women and are not indicated in this population.

🆘 Overdosage 29 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action • Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

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

12.3Pharmacokinetics Absorption Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate. Peak serum concentrations of NGMN and EE are generally reached by 2 hours after administration of norgestimate and ethinyl estradiol.

Accumulation following multiple dosing of the 250 mcg NGM / 35 mcg EE dose is approximately 2-fold for NGMN and EE compared with single dose administration. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Steady-state concentration of EE is achieved by Day 7 of each dosing cycle.

Steady-state concentrations of NGMN and NG are achieved by Day 21. Non-linear accumulation (approximately 8 fold) of NG is observed as a result of high-affinity binding to SHBG, which limits its biological activity (Table 3). Table 3: Summary of NGMN, NG and EE pharmacokinetic parameters.

C max = peak serum concentration, t max = time to reach peak serum concentration, AUC 0–24h = area under serum concentration vs time curve from 0 to 24 hours, t 1/2 = elimination half-life, NC = not calculated. NGMN and NG: C max = ng/mL, AUC 0–24h = h∙ng/mL EE: C max = pg/mL, AUC 0–24h = h∙pg/mL Mean (SD) Pharmacokinetic Parameters of Norgestimate and Ethinyl Estradiol During a Three Cycle Study Analyte Cycle Day C max t max (h) AUC 0–24h t 1/2 (h) NGMN 1 1 1.78 (0.397) 1.19 (0.250) 9.90 (3.25) 18.4 (5.91) 3 21 2.19 (0.655) 1.43 (0.680) 18.1 (5.53) 24.9 (9.04) NG 1 1 0.649 (0.49) 1.42 (0.69) 6.22 (2.46) 37.8 (14) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45 (20.4) EE 1 1 92.2 (24.5) 1.2 (0.26) 629 (138) 10.1 (1.90) 3 21 147 (41.5) 1.13 (0.23) 1210 (294) 15 (2.36) Food Effect The effect of food on the pharmacokinetics of norgestimate and ethinyl estradiol has not been studied.

Distribution NGMN and NG are highly bound (>97%) to serum proteins. NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG. EE is extensively bound (>97%) to serum albumin and induces an increase in the serum concentrations of SHBG.

Metabolism NGM is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. NGM's primary active metabolite is NGMN. Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites.

Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (K i ). EE is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates. Excretion The metabolites of NGMN and EE are eliminated by renal and fecal pathways.

Following administration of 14 C-norgestimate, 47% (45 to 49%) and 37% (16 to 49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged NGM was not detected in the urine. In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM.

These include 18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17α)-(-);18,19-Dinor-5β-17-pregnan-20-yn,3α,17β-dihydroxy-13-ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites.

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action • Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

📦 How Supplied / Storage and Handling 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Estarylla (norgestimate and ethinyl estradiol tablets, USP) are available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are blue, round, debossed with SZ on one side and T4 on the other side. The 7 inert tablets are green, round, debossed with SZ on one side and J1 on the other side. NDC 70700-119-85, one carton containing 3 blister cards

16.2Storage Conditions • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. • Protect from light. Keep out of reach of children

📋 Description 109 words ▾

11 DESCRIPTION Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). • Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of the ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch. • Each green placebo tablet containing only inert ingredients, as follows: crospovidone, D & C Yellow No.10 Aluminum Lake, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch.

Norgestimate Structure Ethinyl Estradiol Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information and Instructions for Use ). Counsel patients about the following information: • Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ] . • Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see WARNINGS AND PRECAUTIONS (5.1) ]. • Estarylla does not protect against HIV infection (AIDS) and other sexually transmitted infections. • Estarylla is not to be used during pregnancy; if pregnancy occurs during use of Estarylla instruct the patient to stop further use [see WARNINGS AND PRECAUTIONS ( 5.9 )]. • Take one tablet daily by mouth at the same time every day.

Instruct patients what to do in the event tablets are missed [see DOSAGE AND ADMINISTRATION (2.2) ]. • Use a back-up or alternative method of contraception when enzyme inducers are used with Estarylla [see DRUG INTERACTIONS (7.1) ]. • COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see USE IN SPECIFIC POPULATIONS (8.3) ]. • Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days [see DOSAGE AND ADMINISTRATION (2.2) ]. • Amenorrhea may occur.

Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see WARNINGS AND PRECAUTIONS ( 5.8 )]. ESTARYLLA is a registered trademark of Xiromed Pharma España, S.L.

Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain PI-119-02 Rev. 02/2023 Patient Information Estarylla ® ( norgestimate and ethinyl estradiol tablets, USP) ( nor-JES- ti -mate , ETH- i -nil es - tra -DYE- ol ) What is the most important information I should know about Estarylla ? Do not use Estarylla if you smoke cigarettes and are over 35 years old.

Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. What is Estarylla ?

Estarylla is a birth control pill (oral contraceptive) used by women to prevent pregnancy. How does Estarylla work for contraception? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills.

The better you follow the directions, the less chance you have of getting pregnant. Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Estarylla. The following chart shows the chance of getting pregnant for women who use different methods of birth control.

Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Who should not take Estarylla ? Do not take Estarylla if you: smoke and are over 35 years of age had blood clots in your arms, legs, lungs, or eyes had a problem with your blood that makes it clot more than normal have certain heart valve problems or irregular heart beat that increases your risk of having blood clots had a stroke had a heart attack have high blood pressure that cannot be controlled by medicine have diabetes with kidney, eye, nerve, or blood vessel damage have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age have liver problems, in… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 62 words ▾

8.3Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate. Peak serum concentrations of NGMN and EE are generally reached by 2 hours after administration of norgestimate and ethinyl estradiol.

Accumulation following multiple dosing of the 250 mcg NGM / 35 mcg EE dose is approximately 2-fold for NGMN and EE compared with single dose administration. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Steady-state concentration of EE is achieved by Day 7 of each dosing cycle.

Steady-state concentrations of NGMN and NG are achieved by Day 21. Non-linear accumulation (approximately 8 fold) of NG is observed as a result of high-affinity binding to SHBG, which limits its biological activity (Table 3). Table 3: Summary of NGMN, NG and EE pharmacokinetic parameters.

C max = peak serum concentration, t max = time to reach peak serum concentration, AUC 0–24h = area under serum concentration vs time curve from 0 to 24 hours, t 1/2 = elimination half-life, NC = not calculated. NGMN and NG: C max = ng/mL, AUC 0–24h = h∙ng/mL EE: C max = pg/mL, AUC 0–24h = h∙pg/mL Mean (SD) Pharmacokinetic Parameters of Norgestimate and Ethinyl Estradiol During a Three Cycle Study Analyte Cycle Day C max t max (h) AUC 0–24h t 1/2 (h) NGMN 1 1 1.78 (0.397) 1.19 (0.250) 9.90 (3.25) 18.4 (5.91) 3 21 2.19 (0.655) 1.43 (0.680) 18.1 (5.53) 24.9 (9.04) NG 1 1 0.649 (0.49) 1.42 (0.69) 6.22 (2.46) 37.8 (14) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45 (20.4) EE 1 1 92.2 (24.5) 1.2 (0.26) 629 (138) 10.1 (1.90) 3 21 147 (41.5) 1.13 (0.23) 1210 (294) 15 (2.36) Food Effect The effect of food on the pharmacokinetics of norgestimate and ethinyl estradiol has not been studied.

Distribution NGMN and NG are highly bound (>97%) to serum proteins. NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG. EE is extensively bound (>97%) to serum albumin and induces an increase in the serum concentrations of SHBG.

Metabolism NGM is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. NGM's primary active metabolite is NGMN. Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites.

Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (K i ). EE is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates. Excretion The metabolites of NGMN and EE are eliminated by renal and fecal pathways.

Following administration of 14 C-norgestimate, 47% (45 to 49%) and 37% (16 to 49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged NGM was not detected in the urine. In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM.

These include 18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17α)-(-);18,19-Dinor-5β-17-pregnan-20-yn,3α,17β-dihydroxy-13-ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites.

🧬 Pharmacodynamics 13 words ▾

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

🔬 Clinical Studies 99 words ▾

14 CLINICAL STUDIES

14.1Contraception In three US clinical trials with norgestimate and ethinyl estradiol, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to 13% African-American, 6 to 14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs.

The pregnancy rate was approximately 1 pregnancy per 100 women-years.

🧪 Nonclinical Toxicology 26 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See WARNINGS AND PRECAUTIONS ( 5.2 , 5.11 ) and USE IN SPECIFIC POPULATIONS ( 8.1 ).]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 23 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See WARNINGS AND PRECAUTIONS ( 5.2 , 5.11 ) and USE IN SPECIFIC POPULATIONS ( 8.1 ).]

📄 Recent Major Changes 9 words ▾

Recent Major Changes Warnings and Precautions (5.11 ) 11/2021

📄 Package Label / Principal Display Panel 19 words ▾

Principal Display Panel NDC 70700-119-85 Estarylla ® ( Norgestimate and Ethinyl Estradiol Tablets, USP) 0.25 mg/0.035 mg Rx only

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
170.3K
Units reimbursed last 4 qtrs
8.7M
Gross reimbursed last 4 qtrs
$2.46M
Avg / prescription
$14.44
Avg / unit
$0.2815
Latest quarter Q1 2026
25.2KRx
Medicaid pays / ea
$0.2815
gross reimbursed
vs
NADAC / ea
$0.1148
acquisition cost
=
Spread
+$0.1667
+145% 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 ⓘ
34% FFS 66% MCO
Fee-for-service · 58,035 Rx Managed care · 112,284 Rx
State Medicaid map
Alaska: 6,356 units · 867 per 100k residents AK Maine: 121,912 units · 8,739 per 100k residents ME Washington: 72,156 units · 924 per 100k residents WA Idaho: 76,636 units · 3,902 per 100k residents ID Montana: 21,616 units · 1,910 per 100k residents MT North Dakota: 11,172 units · 1,427 per 100k residents ND Minnesota: 324,415 units · 5,655 per 100k residents MN Wisconsin: 333,165 units · 5,637 per 100k residents WI Michigan: 456,238 units · 4,546 per 100k residents MI New York: 324,572 units · 1,658 per 100k residents NY Vermont: 18,900 units · 2,921 per 100k residents VT New Hampshire: 57,904 units · 4,130 per 100k residents NH Oregon: 71,042 units · 1,678 per 100k residents OR Nevada: 111,496 units · 3,491 per 100k residents NV Wyoming: 9,184 units · 1,573 per 100k residents WY South Dakota: 26,656 units · 2,901 per 100k residents SD Iowa: 156,884 units · 4,892 per 100k residents IA Illinois: 564,316 units · 4,497 per 100k residents IL Indiana: 131,376 units · 1,915 per 100k residents IN Ohio: 359,644 units · 3,052 per 100k residents OH Pennsylvania: 160,720 units · 1,240 per 100k residents PA New Jersey: 114,242 units · 1,230 per 100k residents NJ Massachusetts: 88,144 units · 1,259 per 100k residents MA California: 773,367 units · 1,985 per 100k residents CA Utah: 25,090 units · 734 per 100k residents UT Colorado: 193,368 units · 3,290 per 100k residents CO Nebraska: 115,836 units · 5,856 per 100k residents NE Missouri: 253,512 units · 4,092 per 100k residents MO Kentucky: 279,272 units · 6,170 per 100k residents KY West Virginia: 75,852 units · 4,285 per 100k residents WV Virginia: 90,356 units · 1,037 per 100k residents VA Maryland: 63,168 units · 1,022 per 100k residents MD Connecticut: 69,223 units · 1,914 per 100k residents CT Rhode Island: 56,476 units · 5,158 per 100k residents RI Arizona: 163,296 units · 2,197 per 100k residents AZ New Mexico: 164,250 units · 7,770 per 100k residents NM Kansas: 75,908 units · 2,582 per 100k residents KS Arkansas: 70,616 units · 2,302 per 100k residents AR Tennessee: 253,178 units · 3,553 per 100k residents TN North Carolina: 420,170 units · 3,878 per 100k residents NC South Carolina: 78,232 units · 1,456 per 100k residents SC Delaware: 20,244 units · 1,964 per 100k residents DE Oklahoma: 180,964 units · 4,465 per 100k residents OK Louisiana: 434,476 units · 9,499 per 100k residents LA Mississippi: 92,544 units · 3,148 per 100k residents MS Alabama: 98,812 units · 1,934 per 100k residents AL Georgia: 79,442 units · 720 per 100k residents GA D.C.: 3,696 units · 544 per 100k residents DC Hawaii: 24,920 units · 1,737 per 100k residents HI Texas: 677,108 units · 2,220 per 100k residents TX Florida: 287,154 units · 1,270 per 100k residents FL
Units reimbursed · per 100k residents
5449,499
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 Louisiana 9,499 /100k
2 Maine 8,739 /100k
3 New Mexico 7,770 /100k
4 Kentucky 6,170 /100k
5 Nebraska 5,856 /100k
6 Minnesota 5,655 /100k
7 Wisconsin 5,637 /100k
8 Rhode Island 5,158 /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 Estarylla — 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 Estarylla. 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
$37.5K
Claims incl. refills
1.9K
Beneficiaries
1.2K
Spend / beneficiary
$31.40
Spend / claim
$20.17
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 Estarylla (this brand).

Top reported reactions

Nausea74
Headache60
Pregnancy On Oral Contraceptive56
Vomiting49
Drug Interaction43
Rash42
Pain41

Age at onset

Adolescent9
Adult133

Reporter sex

1,070 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Hospitalization177
Life-threatening33
Death17
Disabling16
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 111 0
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.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

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

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

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Xiromed, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Xiromed, 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.
← 70700-0118-85 · Xiromed, 70700-0120-85 · Xiromed, →
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.