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Introvale Levonorgestrel and Ethinyl Estradiol Kit, 1 kit — NDC 70700-117-87 (Billing 70700-0117-87)

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

This is a package of 1 kit of Introvale Levonorgestrel and Ethinyl Estradiol Kit from Xiromed, LLC., marketed since Feb 2018 and currently FDA-listed; retail pharmacies pay about $0.1840 per kit (NADAC). It is this product's only package size.

NDC 70700-0117-87
🏷️ FDA NDC (as labeled) 70700-117-87 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70700-117-87
Product NDC 70700-117
11-digit billing NDC 70700011787
NCPDP billing unit EA — each (per item)
RxCUI 238019, 748797, 751901, 1020155
UPC 0370700117873
Application # ANDA079064
SPL Set ID f5bc2427-3a18-e3e6-a058-210688e9c446
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-01
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 25993002300320
GPI class Introvale
GCN Seq No 053076
GCN 20414
HICL code 001460
Ingredient (HICL) Levonorgestrel/Ethin.estradiol
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name INTROVALE 0.15-0.03 MG TABLET
FDB brand name Introvale
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053076
  • GCN: 20414
  • GPI-14 (Medi-Span): 25993002300320
  • HICL (First Databank): 001460
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 238019
Why two NDCs? The FDA registers this code as 70700-117-87 — 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 → 70700-0117-87. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Estrogen class.

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

Clinical

Label name INTROVALE 0.15-0.03 MG TABLET Ingredient Levonorgestrel/Ethin.estradiol
📗 Our plain-language guide HelloPharmacist
  • It prevents pregnancy. It is a combined hormonal birth control with an estrogen and a progestin. It comes as daily tablets or as the weekly Twirla patch.
  • With tablets, you take one at the same time every day, no more than 24 hours apart. With the Twirla patch, you wear one patch for a week, three weeks in a row, then take a patch-fr...
  • Headache, nausea, acne, breast tenderness, mood changes, and irregular bleeding are the common ones. Bleeding changes often settle with time. Call your doctor if they persist.
  • Get help for chest pain, sudden shortness of breath, leg swelling or pain, vision loss, or severe new headaches. These can signal a blood clot or stroke. Also report yellowing of y...
📖 Read our full Ethinyl Estradiol / Levonorgestrel guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.184 $0.18 / 1 kit
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4480 $0.45 / 1 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.226 $0.173
▼ Down 4% over the last 12 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
70700-0117-87 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2018-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued save 39%
Altavera 70700-0116-85 Xiromed, 1 kit $0.114 AB Availability likely save 38%
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.114 AB Availability likely save 38%
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.114 AB Availability likely save 38%
Marlissa 68462-0388-29 Glenmark 1 kit $0.114 AB Availability likely save 38%
Kurvelo 68180-0844-73 Lupin 63 tablets $0.114 AB Availability likely save 38%
Portia 00555-9020-58 Teva 6 pouches $0.114 — Availability likely save 38%
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely save 32%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued save 21%
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely save 18%
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued save 17%
Lessina 00555-9014-67 Teva 3 pouches $0.154 — Availability likely save 17%
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.154 AB1 Availability likely save 17%
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.154 AB1 Availability likely save 17%
Aviane 00555-9045-58 Teva 6 pouches $0.154 — Availability likely save 17%
Vienva 70700-0118-85 Xiromed, 1 kit $0.154 AB1 Availability likely save 17%
Falmina 16714-0359-01 Northstar 1 packet $0.154 AB1 Availability likely save 17%
Sronyx 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued save 5%
Introvalethis 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed —
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed +22%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed +23%
Setlakin 16714-0366-03 Northstar 3 pouches $0.227 AB Availability likely +23%
Levonorgestrel and Ethinyl Estradiol 68180-0843-13 Lupin 1 kit $0.227 AB Availability likely +23%
levonorgestrel and ethinyl estradiol 68462-0672-95 Glenmark 3 pouches $0.227 AB Availability likely +23%
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 Lupin 2 pouches $0.239 AB Availability likely +30%
Levonest 16714-0340-01 Northstar 1 packet $0.324 AB Availability likely +76%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.324 AB Availability likely +76%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 — Availability likely +350%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.445 AB3 Availability likely +1773%
Levonest 50090-2505-00 A-S 1 kit — AB FDA listed —
Kurvelo 50090-6374-00 A-S 21 tablets — AB FDA listed —
Altavera 63629-2343-01 Bryant 1 kit — AB FDA listed —
Lutera 55741-0005-06 Dr. 1 kit — AB1 FDA listed —
Balcoltra 75854-0602-02 Avion 1 kit — AB3 FDA listed —
Vienva Tm 50090-5580-00 A-S 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 79929-0003-07 Naari 1 kit — AB FDA listed —
Levonorgestrel and Ethinyl Estradiol 60505-4898-08 Apotex 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 60505-4899-08 Apotex 1 kit — AB FDA listed —
Vienva TM 63629-2344-01 Bryant 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 79929-0004-07 Naari 1 kit — AB1 FDA listed —
Aviane 63187-0889-28 Proficient 1 pouch — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Feb 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 applicationANDA079064 (ANDA)
Labeler code70700
First marketedFeb 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 116 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. Introvale (levonorgestrel and ethinyl estradiol tablets) is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

( 4 )

🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Introvale ® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Introvale is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day for 91 days. ( 2.1 ) • Take tablets in the order directed on the Extended-Cycle Blister Cards. ( 2.2 )

2.1How to Start Introvale Introvale is dispensed in an Extended-Cycle Blister Card [see How Supplied/Storage and Handling ( 16 )] . Introvale should be started on a Sunday ( see Table 1 ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

Instruct patients to take Introvale once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Introvale should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling .

2.2How to Take Introvale Table 1 Instructions for Administration of Introvale Starting COCs in women not currently using hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Introvale active tablets are peach (Day 1 to Day 84). Introvale inactive tablets are white (Day 85 to Day 91).

Sunday Start: For each 91-day course, take in the following order: Take the first peach tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment.

Take subsequent peach tablets once daily at the same time each day for a total of 84 days. Take one white tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the white tablets are taken.

Begin the next and all subsequent 91-day courses of Introvale without interruption on the same day of the week (i.e., Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a peach tablet once a day for 84 days, and a white tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a peach tablet daily for 7 consecutive days.

Switching to Introvale from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Introvale Start Introvale: Transdermal patch On the day when the next application would have been scheduled. Vaginal ring On the day when the next insertion would have been scheduled.

Injection On the day when the next injection would have been scheduled. Intrauterine contraceptive (IUD) On the day of removal. If the IUD is not removed on first day of the patient’s menstrual cycle, additional non- hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course. days of the first 91-day course.

Implant On the day of removal. Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-approved patient labeling. Starting Introvale after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Introvale may be started immediately.

An additional method of contraception is not needed if Introvale is started immediately. If Introvale is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of Introvale. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 110 words ▾

3 DOSAGE FORMS AND STRENGTHS Introvale (levonorgestrel and ethinyl estradiol tablets) are available as round, film-coated, debossed “ SZ ” on one side, packaged in a unit carton, each containing a 13-week supply of tablets in the following order: • 84 peach tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with “ J4 ” on the other side • 7 white inert tablets debossed with “ J1 ” on the other side. Introvale (levonorgestrel and ethinyl estradiol tablets, USP) consists of 84 round, peach tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, white inert tablets.

( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Introvale 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 ) and Use in Specific Populations ( 8.6 ) ].

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 (5.9) 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 combination 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 ) Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 ) Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Thrombotic disorders and other vascular problems: Stop levonorgestrel 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 levonorgestrel and ethinyl estradiol if jaundice occurs. ( 5.2 ) • High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop levonorgestrel and ethinyl estradiol if blood pressure rises significantly. ( 5.4 ) • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol.

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

( 5.8 )

5.1Thrombotic Disorders and Other Vascular Problems Stop levonorgestrel and ethinyl estradiol if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop levonorgestrel and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

If feasible, stop levonorgestrel and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start levonorgestrel 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 levonorgestrel and ethinyl estradiol provides women with more hormonal exposure on a yearly basis than conventional monthly COCs containing the same strength synthetic estrogens and progestins (an additional 9 weeks of exposure per year).

In the clinical trial, one case of pulmonary embolism was reported. Postmarketing adverse reactions of VTE have been reported in women who used levonorgestrel and ethinyl estradiol. 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.

Stroke has been reported in women associated with the use of levonorgestrel and ethinyl estradiol. 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 levonorgestrel and ethinyl estradiol in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the 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 levonorgestrel and ethinyl estradiol if jaundice develops.

Liver Tumors Levonorgestrel and ethinyl estradiol is contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )]. Hepatic adenomas are associated with COC u… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 1-844-XIROMED (1-844-947-6633) 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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of levonorgestrel and ethinyl estradiol (345.14 woman-years of exposure) [see Clinical Studies (14)].

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

Serious Adverse Reactions: pulmonary embolus, cholecystitis.

6.2Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure A). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure A). 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 A: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following adverse reactions have been identified during post-approval use of levonorgestrel and ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: abdominal distension, vomiting General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema Investigations: blood pressure increased Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity Nervous system disorders: dizziness, loss of consciousness Psychiatric disorders: insomnia Reproductive and breast disorders: dysmenorrhea Skin and s… [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. Drugs or herbal products that induce certain enzymes (for example 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 and potentially diminishing the efficacy 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 oral 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., 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 [see Warnings and Precautions ( 5.12 )].

7.3Concomitant Use with Hepatitis C Vaccine (HCV) Combination Therapy - Liver Enzyme Elevation Do not administer Introvale with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.

7.4Interactions with Laboratory Tests The use of contraceptive steroids may inf… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Nursing Mothers: Advise use of another contraceptive method. Levonorgestrel and ethinyl estradiol 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 levonorgestrel and ethinyl estradiol have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol before menarche is not indicated.

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

8.6Hepatic Impairment The pharmacokinetics of levonorgestrel and ethinyl estradiol have not been studied in subjects with hepatic impairment. However, 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 levonorgestrel and ethinyl estradiol have not been studied in women with renal impairment.

🤰 Pregnancy 81 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 52 words ▾

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

🧓 Geriatric Use 21 words ▾

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

🆘 Overdosage 29 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action COCs 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 levonorgestrel and ethinyl estradiol.

12.3Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. EE is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of EE is approximately 43%.

Following continuous dosing with once-daily administration of levonorgestrel and ethinyl estradiol tablets, plasma concentrations of levonorgestrel and EE reached steady-state within 7 days. The mean plasma pharmacokinetic parameters for levonorgestrel and ethinyl estradiol under fasting conditions in normal healthy women following once-daily administration of one levonorgestrel/EE combination tablet for 10 days are summarized in Table 5. Table 5 Mean ±SD Pharmacokinetic Parameters Under Fasting Conditions in Healthy Women Following 10 Days Administration of One Tablet of Levonorgestrel and Ethinyl Estradiol (n=44) Analyte AUC 0-24 C max C min C avg a T max Levonorgestrel 54.6 ± 16.5 ng*hr/mL 5 ± 1.5 ng/mL 1.6 ± 0.5 ng/mL 2.3 ± 0.7 ng/mL 1.4 ± 0.7 hours Ethinyl Estradiol 935.5 ± 346.9 pg*hr/mL 106.1 ± 41.2 pg/mL 18.5±9.4 pg/mL 38.9 ± 14.4 pg/mL 1.6 ± 0.6 hours a Cavg = AUC0-24/24 Food Effect The effect of food on the rate and the extent of levonorgestrel and EE absorption following oral administration of levonorgestrel and ethinyl estradiol has not been evaluated.

Distribution The apparent volume of distribution of levonorgestrel and EE are reported to be approximately

1.8 L/kg and

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

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

Significant amounts of conjugated and unconjugated 3α,5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α,5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

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

The various hydroxylated metabolites are subject to further methylation and/or conjugation. Excretion About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32%… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 36 words ▾

12.1Mechanism of Action 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 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Introvale tablets (levonorgestrel and ethinyl estradiol, USP) are available in extended-cycle blister cards (NDC 70700-117-87 ) , each containing a 13-week supply of tablets: 84 peach active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 white inert tablets packaged in a unit carton. The active tablets are peach, round, film-coated, debossed “ SZ ” on one side and “ J4 ” on the other side. The inert tablets are white, round, film-coated, debossed with “ SZ ” on one side and “ J1 ” on the other side.

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

📋 Description 136 words ▾

11 DESCRIPTION Introvale (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 peach active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW:312.4 Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol C 20 H 24 O 2 MW:296.4 Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.

Each peach active tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, iron oxide yellow, iron oxide red and iron oxide black. Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. structure1 structure2

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients on 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 )].

Introvale does not protect against HIV-infection (AIDS) and other sexually transmitted infections. Introvale is not to be used during pregnancy; if pregnancy occurs during use of Introvale, instruct the patient to stop further use [see Warnings and Precautions ( 5.8 )]. 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 ( 2.3 )]. Use a back-up or alternative method of contraception when enzyme inducers are used with Introvale [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 on COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken a peach tablet for 7 consecutive days [see Dosage and Administration ( 2.2 )]. Amenorrhea may occur. Because women using Introvale will likely have scheduled bleeding only 4 times per year, rule out pregnancy at the time of any missed menstrual period [see Warnings and Precautions ( 5.7 )].

INTROVALE 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 Rev. 06/2022 PI-117-03

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. EE is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of EE is approximately 43%.

Following continuous dosing with once-daily administration of levonorgestrel and ethinyl estradiol tablets, plasma concentrations of levonorgestrel and EE reached steady-state within 7 days. The mean plasma pharmacokinetic parameters for levonorgestrel and ethinyl estradiol under fasting conditions in normal healthy women following once-daily administration of one levonorgestrel/EE combination tablet for 10 days are summarized in Table 5. Table 5 Mean ±SD Pharmacokinetic Parameters Under Fasting Conditions in Healthy Women Following 10 Days Administration of One Tablet of Levonorgestrel and Ethinyl Estradiol (n=44) Analyte AUC 0-24 C max C min C avg a T max Levonorgestrel 54.6 ± 16.5 ng*hr/mL 5 ± 1.5 ng/mL 1.6 ± 0.5 ng/mL 2.3 ± 0.7 ng/mL 1.4 ± 0.7 hours Ethinyl Estradiol 935.5 ± 346.9 pg*hr/mL 106.1 ± 41.2 pg/mL 18.5±9.4 pg/mL 38.9 ± 14.4 pg/mL 1.6 ± 0.6 hours a Cavg = AUC0-24/24 Food Effect The effect of food on the rate and the extent of levonorgestrel and EE absorption following oral administration of levonorgestrel and ethinyl estradiol has not been evaluated.

Distribution The apparent volume of distribution of levonorgestrel and EE are reported to be approximately

1.8 L/kg and

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

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

Significant amounts of conjugated and unconjugated 3α,5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α,5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

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

The various hydroxylated metabolites are subject to further methylation and/or conjugation. Excretion About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of levonorgestrel and ethinyl estradiol was about 30 hours.

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

🧬 Pharmacodynamics 13 words ▾

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

🔬 Clinical Studies 203 words ▾

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

The weight range of those women treated was 84 to 304 pounds, with a mean weight of 157 pounds and a median weight of 147 pounds. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 29% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 8% were new starts. The pregnancy rate (Pearl Index [PI]) in the 397 women aged 18 to 35 years was 1.98 pregnancies per 100 women-years of use (95% CI: 0.54 to 5.03), based on 4 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill.

Cycles in which conception did not occur, but which included the use of back-up contraception, were not included in the calculation of the PI.

🧪 Nonclinical Toxicology 26 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions ( 5.2 , 5.10 ) 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 , 5.10 ) and Use in Specific Populations ( 8.1 )].

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Introvale ® Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg (lee-voe-nor-JES-trel ETH-in-il es-tra-DIE-ole) What is the most important information I should know about Introvale? Do not use Introvale 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 Introvale? Introvale is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Introvale 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 to 5 out of 100 women may get pregnant during the first year they use Introvale. 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 Introvale?

Do not take Introvale 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 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, including liver tumors take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood. have any unexplained vaginal bleeding are pregnant had breast cancer or any cancer that is sensitive to female hormones If any of these conditions happen while you are taking Introvale, stop taking Introvale right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Introvale. What should I tell my healthcare provider before taking Introvale?

Tell your healthcare provider if you: are pregnant or think you may be pregnant are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed. Introvale may decrease the amount of breast milk you make. A small amount of the hormones in levonorgestrel and ethinyl estradiol may pass into your breast milk.

Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Introvale may affect the way other medicines work, and other medicines may affect how well Introvale works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take Introvale?

Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of Introvale? Like pregnancy, Introvale may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death.

Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions For Use Introvale (levonorgestrel and ethinyl estradiol tablets, USP) (lee-voe-nor-JES-trel ETH-in-il es-tra-DIE-ole) Important Information about taking Introvale Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser. Do not skip your pills, even if you do not have sex often.

If you miss pills (including starting the pack late) you could get pregnant . The more pills you miss, the more likely you are to get pregnant. If you have trouble remembering to take Introvale, talk to your healthcare provider.

When you first start taking Introvale, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. You may feel sick to your stomach (nauseous), especially during the first few months of taking Introvale.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.

Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see What should I do if I miss any Introvale pills? below), you could also feel a little sick to your stomach. It is not uncommon to miss a period.

However, if you miss a period and have not taken Introvale according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Introvale. If you have vomiting or diarrhea within 3 to 4 hours of taking a peach pill, take another peach pill as soon as possible.

Continue taking one pill a day until the 91-day course is finished. If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider.

Stop taking Introvale at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period. Before you start taking Introvale: Decide what time of day you want to take your pill.

It is important to take it at about the same time every day. Look at your Extended-Cycle Blister Cards. Your Tablet Dispenser consists of a Tri-Fold Blister Card that holds 91 individually sealed pills (a 13-week, or 91-day, cycle).

The 91 pills consist of 84 peach pills (active pills with hormones) and 7 white pills (inactive pills without hormone) arranged in 12 rows of 7 tablets each, labeled weeks “START” through “Week 12” (active pills with hormones) followed by 1 row of 7 white pills, labeled “Week 13” (inactive pills without hormone). Also find: o Where on the first tray in the pack to start taking pills (upper left corner) and o In what order to take the pills (follow the weeks) Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking Introvale? If you start taking Introvale and you have not used a hormonal birth control method before: Take the first peach pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first peach pill that same day.

Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first peach pill until the next Sunday (first 7 days). If you start taking Introvale and you are switching from another birth control pill: Start your new Introvale pack on the same day that you would start the next pack of your previous birth control method. Do not continue taking the pills from your previous birth control pack.

If you start taking Introvale and previously used a vaginal ring: Start using Introvale on the day you wo… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

Warnings and Precautions, Malignant Neoplasms ( 5.11 ) 04/2022

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Introvale (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg - NDC 70700-117-87 - Carton Label image description

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

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

Medicare Part D (outpatient prescription) spending for Introvale — 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 Introvale. 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
$35.2K
Claims incl. refills
597
Beneficiaries
575
Spend / beneficiary
$61.27
Spend / claim
$59.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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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) — 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

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.
← 70700-0116-85 · Xiromed, 70700-0118-85 · 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.