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Tri-Estarylla norgestimate and ethinyl estradiol Kit — NDC 70700-0121-85 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tri-Estarylla norgestimate and ethinyl estradiol Kit — NDC 70700-121-85 (Billing 70700-0121-85)

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

This is a package of Tri-Estarylla norgestimate and ethinyl estradiol Kit from Xiromed, LLC., marketed since Sep 2022 and currently FDA-listed; retail pharmacies pay about $0.1264 per unit (NADAC). It is this product's only package size.

NDC 70700-0121-85
🏷️ FDA NDC (as labeled) 70700-121-85 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) 70700-121-85
Product NDC 70700-121
11-digit billing NDC 70700012185
NCPDP billing unit EA — each (per item)
RxCUI 240128, 406396, 687424, 748797, 749784, 1369770
Application # ANDA090793
SPL Set ID 1ba8a8ab-eb09-0807-47d4-6b4055d10d91
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-01
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 25992002300320
GPI class Tri-Estarylla
GCN Seq No 016963
GCN 11301
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 TRI-ESTARYLLA TABLET
FDB brand name Tri-Estarylla
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016963
  • GCN: 11301
  • GPI-14 (Medi-Span): 25992002300320
  • HICL (First Databank): 004845
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 240128
Why two NDCs? The FDA registers this code as 70700-121-85 — 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 → 70700-0121-85. 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 TRI-ESTARYLLA 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 $0.126 $0.38 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.2853 $0.86 / 3 kit
Medicare drug plans payPart D · Q2 2026 $0.2380 $0.71 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.173 $0.126
▼ Down 27% 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
70700-0121-85 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2023-02-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tri-Lo-Sprintec 00093-2140-62 Teva 3 pouches $0.108 AB Availability likely save 15%
Tri-Lo-Mili 65862-0778-28 Aurobindo 1 kit $0.108 AB Availability likely save 15%
Tri-VyLibra Lo 50102-0231-13 Afaxys 1 kit $0.108 AB Availability likely save 15%
Tri-Lo- Estarylla 70700-0120-85 Xiromed, 1 kit $0.108 AB Availability likely save 15%
Tri-Lo-Marzia 68180-0837-73 Lupin 3 pouches $0.108 AB Availability likely save 15%
Estarylla 70700-0119-85 Xiromed, 1 kit $0.115 AB Availability likely save 9%
Sprintec 00555-9016-58 Teva 6 pouches $0.115 AB Availability likely save 9%
VyLibra 50102-0235-11 Afaxys 1 kit $0.115 AB Availability likely save 9%
Mono-Linyah 16714-0360-01 Northstar 1 packet $0.115 AB Availability likely save 9%
Mili 65862-0776-28 Aurobindo 1 kit $0.115 AB Availability likely save 9%
Norgestimate and Ethinyl Estradiol 68462-0309-29 Glenmark 1 kit $0.115 AB Availability likely save 9%
Norgestimate and Ethinyl Estradiol 68180-0840-73 Lupin 3 pouches $0.115 AB Availability likely save 9%
Tri-Mili 65862-0777-28 Aurobindo 1 kit $0.126 AB Availability likely —
Tri-Estaryllathis 70700-0121-85 Xiromed, 1 kit $0.126 AB Availability likely —
Norgestimate and Ethinyl Estradiol 68462-0565-29 Glenmark 1 kit $0.126 AB Availability likely —
Tri-Sprintec 00555-9018-58 Teva 6 pouches $0.126 AB Availability likely —
Norgestimate and ethinyl estradiol 68180-0838-73 Lupin 1 kit $0.126 AB Availability likely —
Tri-VyLibra 50102-0233-11 Afaxys 1 kit $0.126 AB Availability likely —
Tri-Linyah 16714-0363-01 Northstar 1 packet $0.126 AB Availability likely —
Nymyo 51862-0645-01 Mayne 1 packet $0.135 AB FDA listed +7%
Tri-Nymyo 51862-0646-01 Mayne 1 packet $0.140 AB FDA listed +11%
Tri Femynor 69238-1607-06 Amneal 1 kit $0.140 — FDA listed +11%
Femynor 69238-1551-06 Amneal 1 kit $0.144 — FDA listed +14%
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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerXiromed, LLC.
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA090793 (ANDA)
Labeler code70700
First marketedSep 2022
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 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 114 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. • Tri- Estarylla is 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 177 words ▾

1 INDICATIONS AND USAGE Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

( 1.2 )

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

1.2Acne Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [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. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) Do not skip or delay tablet intake. ( 2.1 )

2.1Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-Estarylla. Table 1: Instructions for Administration of Tri-Estarylla 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: Tri-Estarylla active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). Tri-Estarylla have 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 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 pack of Tri- 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 pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri- Estarylla 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 Tri- Estarylla Start Tri- 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 pack.

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 Tri-Estarylla after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Tri-Estarylla may be started immediately. An additional method of contraception is not needed if Tri-Estarylla is started immediately.

If Tri-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 Tri-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 Tri-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 pack of Tri-Estarylla. [see CONTRAINDICATIONS ( 4 ) , WARNINGS and PRECAUTIONS ( 5.1 ), and FDA-APPROVED PATIENT LABELING]. Starting Tri-Estarylla after Childbirth Do not start until 4 weeks after delivery, due to the… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 198 words ▾

3 DOSAGE FORMS AND STRENGTHS Tri-Estarylla Tablets are available in blister cards. Each blister pack contains 28 tablets in the following order: 7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. 7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol.

7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. 7 dark green (inert) tablets are round, debossed with SZ on one side and J1 on the other side. Tri-Estarylla (norgestimate and ethinyl estradiol) tablets, USP consists of 28 round, biconvex, coated tablets in the following order ( 3 ): 7 white tablets each containing 0.180 mg norgestimate and 0.035 mg ethinyl estradiol 7 light blue tablets each containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 7 blue tablets each containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 dark green tablets (inert)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Tri-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 hyper coagulopathies [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 ( 5.9 ) 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 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 ) Breast cancer ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • 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 Norgestimate and ethinyl estradiol are contraindicated 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 reg… [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 ANDPRECAUTIONS ( 5.1 )] Vascular events [see WARNINGS ANDPRECAUTIONS ( 5.1 )] Liver disease [see WARNINGS ANDPRECAUTIONS ( 5.2 )] The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 1- (844-947-6633) XIROMED 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 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception.

Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles. Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8.0%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight (including weight fluctuation, increased or decreased) (2.5%).

Adverse Reactions Leading to Study Discontinuation: Over the trials, between 9 to 27% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (4.3%), nausea/vomiting (2.8%), headache/migraine (2.4%), mood disorders (including depression and mood altered) (1.1%), and weight increased (1.1%). Serious Adverse Reactions: breast cancer (1 subject), carcinoma of the cervix in situ (1 subject), hypertension (1 subject), and migraine (2 subjects).

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 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). 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 1: 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; “never COC use” are females that never used COCs.

The following additional adverse reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of unc… [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 20-25%.

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, Non-Nucleoside Reverse Transcriptase inhibitors, and HIV/AIDS Medications Containing Strong Inhibitors or Inducers of CYP3A 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]) or with HIV/AIDS medications containing strong inhibitors (e.g., cobicistat and ritonavir) or inducers of CYP3A.

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… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactating women: Not recommended; can decrease milk production. ( 8.2 )

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy, therefore, Tri-Estarylla (norgestimate and ethinyl estradiol) should be discontinued during pregnancy. Epidemiologic studies and metaanalyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

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

When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for Tri-Estarylla and any potential adverse effects on the breast-fed child from Tri-Estarylla or from the underlying maternal condition.

8.4Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol 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.

There was no significant difference between norgestimate and ethinyl estradiol and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population.

8.5Geriatric Use Norgestimate and ethinyl estradiol has 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 86 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy, therefore, Tri-Estarylla (norgestimate and ethinyl estradiol) should be discontinued during pregnancy. Epidemiologic studies and metaanalyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

🧒 Pediatric Use 105 words ▾

8.4Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol 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.

There was no significant difference between norgestimate and ethinyl estradiol and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population.

🧓 Geriatric Use 21 words ▾

8.5Geriatric Use Norgestimate and ethinyl estradiol has 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. Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sex hormone-binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.

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/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 3 7 1.80 (0.46) 1.42 (0.73) 15 (3.88) NC 14 2.12 (0.56) 1.21 (0.26) 16.1 (4.97) NC 21 2.66 (0.47) 1.29 (0.26) 21.4 (3.46) 22.3 (6.54) NG 3 7 1.94 (0.82) 3.15 (4.05) 34.8 (16.5) NC 14 3.00 (1.04) 2.21 (2.03) 55.2 (23.5) NC 21 3.66 (1.15) 2.58 (2.97) 69.3 (23.8) 40.2 (15.4) EE 3 7 124 (39.5) 1.27 (0.26) 1130 (420) NC 14 128 (38.4) 1.32 (0.25) 1130 (324) NC 21 126 (34.7) 1.31 (0.56) 1090 (359) 15.9 (4.39) 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 (14.0) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45.0 (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) 15.0 (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 metabolit… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 76 words ▾

12.1Mechanism of Action Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sex hormone-binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.

📦 How Supplied / Storage and Handling 183 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tri-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. 7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol .

7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side. NDC 70700-121-85, Carton containing three blister cards.

16.2Storage Conditions • Store at 20º-25ºC (68º-77ºF); excursions permitted to 15° to 30°C (59° to 86°F). • Protect from light. • Keep out of the reach of children.

📋 Description 160 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 white tablet contains 0.180 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, and pregelatinized starch. • Each active light blue tablet contains 0.215 mg norgestimate and 0.035 mg of ethinyl estradiol.

Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch • Each active blue tablet contains 0.250 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch • Each green tablet contains only inert ingredients, as follows: crospovidone, D &C Yellow No.10 Aluminum Lake, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch Chemical Structure 1

💬 Information for Patients ~1 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 )]. • Tri-Estarylla does not protect against HIV infection (AIDS) and other sexually transmitted infections. • Tri-Estarylla is not to be used during pregnancy; if pregnancy occurs during use of Tri-Estarylla instruct the patient to stop further use [see USE IN SPECIFIC POPULATIONS ( 8.1 )]. • 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 ( 2.1 )]. • Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-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 ( 8.2 )]. • 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 ( 2.1 )]. • 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 )]. TRI-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-121-04 Rev. 08/2023

🍼 Nursing Mothers 89 words ▾

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

When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for Tri-Estarylla and any potential adverse effects on the breast-fed child from Tri-Estarylla or from the underlying maternal condition.

🧬 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/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 3 7 1.80 (0.46) 1.42 (0.73) 15 (3.88) NC 14 2.12 (0.56) 1.21 (0.26) 16.1 (4.97) NC 21 2.66 (0.47) 1.29 (0.26) 21.4 (3.46) 22.3 (6.54) NG 3 7 1.94 (0.82) 3.15 (4.05) 34.8 (16.5) NC 14 3.00 (1.04) 2.21 (2.03) 55.2 (23.5) NC 21 3.66 (1.15) 2.58 (2.97) 69.3 (23.8) 40.2 (15.4) EE 3 7 124 (39.5) 1.27 (0.26) 1130 (420) NC 14 128 (38.4) 1.32 (0.25) 1130 (324) NC 21 126 (34.7) 1.31 (0.56) 1090 (359) 15.9 (4.39) 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 (14.0) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45.0 (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) 15.0 (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% (45-49%) and 37% (16-49%) 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 ~2 min read ▾

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 73-86% Caucasian, 8-13% African-American, 6-14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82-303 lbs, with a mean weight of about 135 lbs.

The pregnancy rate was approximately 1 pregnancy per 100 women-years. In four clinical trials with norgestimate and ethinyl estradiol, 4,756 women aged 15 to 41 years were studied for 24 cycles, providing a total of 45,244 cycles of exposure. The racial demographic was about 87-90% Caucasian, 6-10% African-American, with the remainder Asian (≤1%) or Other (2-5%).

There were no exclusions on the basis of weight; the weight range for women treated was 80-310 lbs, with a mean weight of about 132 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.

14.2Acne Norgestimate and ethinyl estradiol was evaluated for the treatment of acne vulgaris in two randomized, double- blind, placebo-controlled, multicenter, six- (28 day) cycle studies. Two hundred twenty- one patients received Tri- norgestimate and ethinyl estradiol and 234 patients received placebo. Mean age at enrollment for both groups was 28 years.

At the end of 6 months, the mean total lesion count changed from 55 to 31 (42% reduction) in patients treated with norgestimate and ethinyl estradiol and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 4 summarizes the changes in lesion count for each type of lesion. Based on the investigator’s global assessment conducted at the final visit, patients treated with norgestimate and ethinyl estradiol showed a statistically significant improvement in total lesions compared to those treated with placebo.

Table 4: Acne Vulgaris Indication. Combined Results: Two Multicenter, Placebo-Controlled Trials. Observed Means at Six Months (LOCF)* and at Baseline.

Intent-to-Treat Population. Tri-Estarylla (N=221) Placebo (N=234) Difference in Counts between Tri-Estarylla and Placebo at 6 Months # of Lesions Counts % Reduction Counts % Reduction INFLAMMATORY LESIONS Baseline Mean 19 48% 19 30% Sixth Month Mean 10 13 3 (95% CI: -1.2, 5.1) NON-INFLAMMATORY LESIONS Baseline Mean 36 34% 35 21% Sixth Month Mean 22 25 3 (95% CI: -0.2, 7.8) TOTAL LESIONS Baseline Mean 55 42% 54 27% 7 (95% CI: 2.0, 11.9) Sixth Month Mean 31 38 *LOCF: Last Observation Carried Forward

🧪 Nonclinical Toxicology 18 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See WARNINGS AND PRECAUTIONS ( 5.2 , 5.10 )].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 15 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See WARNINGS AND PRECAUTIONS ( 5.2 , 5.10 )].

📄 Patient Package Insert ~3 min read ▾

Patient Information Tri- 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 Tri- Estarylla ? Do not use Tri- 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 Tri- Estarylla ? Tri-Estarylla is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

Tri-Estarylla is also used to treat moderate acne vulgaris in females 15 years of age and older, who have no known history of allergies or problems taking birth control pills, and have started their menstrual cycle (“period”). Tri-Estarylla should only be used to treat acne in women who want to take birth control pills to prevent pregnancy. How does Tri- 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 Tri-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 Tri- Estarylla ? Do not take Tri- 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, 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 If any of these conditions happen while you are taking Tri- Estarylla , stop taking Tri- Estarylla right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri- Estarylla . What should I tell my healthcare provider before taking Tri- Estarylla ?

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. Tri-Estarylla may decrease the amount of breast milk you make. A small amount of the hormones in Tri-Estarylla 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. Tri-Estarylla may affect the way other medicines work, and other medicines may affect how well Tri-Estarylla 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 Tri- Estarylla ?

Read the Instructions for Use at the end… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions For Use Tri- Estarylla ® ( norgestimate and ethinyl estradiol tablets, USP) Important Information about taking Tri- Estarylla: Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack. Do not skip your pills, even if you do not have sex often.

If you miss pills (including starting the blister 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 Tri-Estarylla, talk to your healthcare provider.

When you first start taking Tri-Estarylla, 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 Tri-Estarylla.

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 Tri-Estarylla 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 Tri-Estarylla according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Tri-Estarylla. If you have vomiting or diarrhea within 3-4 hours of taking your pill, take another pill of the same color from your extra pill blister pack.

If you do not have an extra pill blister pack, take the next pill in your pill blister pack. Continue taking all your remaining pills in order. Start the first pill of your next pill blister pack the day after finishing your current pill blister pack.

This will be 1 day earlier than originally scheduled. Continue on your new schedule. 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 and a spermicide, until you check with your healthcare provider. Stop taking Tri-Estarylla 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 and spermicide) during this time period.

Before you start taking Tri- Estarylla : Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister pack. Have backup contraception (condoms and spermicide) available and if possible, an extra full blister pack of pills as needed.

When should I start taking Tri- Estarylla ? If you start taking Tri- Estarylla and you have not used a hormonal birth control method before: • There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start).

Your healthcare provider should tell you when to start taking your birth control pill. • If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take Tri-Estarylla. You do not need back-up contraception if you use the Day 1 Start. If you start taking Tri- Estarylla and you are switching from another birth control pill: • Start your new Tri-Estarylla 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 Tri- Estarylla and previously used a vaginal ring or transdermal patch: Start using Tri-Estarylla on the day you would have reapplied the next ring or patch. If you start taking Tri- Estarylla and you are switching from a progest… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

RECENT MAJOR CHANGES Contraindications. Pregnancy ( 4 ) 06/2023

📄 Package Label / Principal Display Panel 25 words ▾

PRINCIPAL DISPLAY PANEL NDC 70700-121-85 Tri- Estarylla ( Norgestimate and Ethinyl Estradiol Tablets, USP) 0.18 mg/0.35 mg, 0.0215 mg/0.35 mg, 0.25 mg/0.35 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
34.5K
Units reimbursed last 4 qtrs
1.7M
Gross reimbursed last 4 qtrs
$488.1K
Avg / prescription
$14.17
Avg / unit
$0.2853
Latest quarter Q1 2026
8.2KRx
Medicaid pays / ea
$0.2853
gross reimbursed
vs
NADAC / ea
$0.1264
acquisition cost
=
Spread
+$0.1589
+126% 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 ⓘ
27% FFS 73% MCO
Fee-for-service · 9,436 Rx Managed care · 25,020 Rx
State Medicaid map
Alaska: no data reported AK Maine: 22,232 units · 1,594 per 100k residents ME Washington: 5,600 units · 71.7 per 100k residents WA Idaho: 2,716 units · 138 per 100k residents ID Montana: 616 units · 54.4 per 100k residents MT North Dakota: 588 units · 75.1 per 100k residents ND Minnesota: 17,248 units · 301 per 100k residents MN Wisconsin: 10,867 units · 184 per 100k residents WI Michigan: 25,946 units · 259 per 100k residents MI New York: 113,324 units · 579 per 100k residents NY Vermont: 9,128 units · 1,411 per 100k residents VT New Hampshire: 14,112 units · 1,007 per 100k residents NH Oregon: 1,736 units · 41.0 per 100k residents OR Nevada: 1,680 units · 52.6 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,716 units · 296 per 100k residents SD Iowa: 10,584 units · 330 per 100k residents IA Illinois: 18,542 units · 148 per 100k residents IL Indiana: 6,580 units · 95.9 per 100k residents IN Ohio: 21,254 units · 180 per 100k residents OH Pennsylvania: 24,136 units · 186 per 100k residents PA New Jersey: 11,516 units · 124 per 100k residents NJ Massachusetts: 221,816 units · 3,168 per 100k residents MA California: 80,463 units · 207 per 100k residents CA Utah: no data reported UT Colorado: 4,284 units · 72.9 per 100k residents CO Nebraska: 2,268 units · 115 per 100k residents NE Missouri: 9,576 units · 155 per 100k residents MO Kentucky: 55,023 units · 1,216 per 100k residents KY West Virginia: 11,368 units · 642 per 100k residents WV Virginia: 151,396 units · 1,737 per 100k residents VA Maryland: 61,180 units · 990 per 100k residents MD Connecticut: 64,540 units · 1,784 per 100k residents CT Rhode Island: 77,476 units · 7,075 per 100k residents RI Arizona: 2,016 units · 27.1 per 100k residents AZ New Mexico: 1,848 units · 87.4 per 100k residents NM Kansas: 504 units · 17.1 per 100k residents KS Arkansas: 4,704 units · 153 per 100k residents AR Tennessee: 40,572 units · 569 per 100k residents TN North Carolina: 200,088 units · 1,847 per 100k residents NC South Carolina: 91,224 units · 1,698 per 100k residents SC Delaware: no data reported DE Oklahoma: 7,056 units · 174 per 100k residents OK Louisiana: 28,954 units · 633 per 100k residents LA Mississippi: 9,912 units · 337 per 100k residents MS Alabama: 20,776 units · 407 per 100k residents AL Georgia: 100,884 units · 915 per 100k residents GA D.C.: 5,908 units · 870 per 100k residents DC Hawaii: 1,652 units · 115 per 100k residents HI Texas: 87,039 units · 285 per 100k residents TX Florida: 47,378 units · 210 per 100k residents FL
Units reimbursed · per 100k residents
17.17,075
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 Rhode Island 7,075 /100k
2 Massachusetts 3,168 /100k
3 North Carolina 1,847 /100k
4 Connecticut 1,784 /100k
5 Virginia 1,737 /100k
6 South Carolina 1,698 /100k
7 Maine 1,594 /100k
8 Vermont 1,411 /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 Tri-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 Tri-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
$21.2K
Claims incl. refills
897
Beneficiaries
583
Spend / beneficiary
$36.34
Spend / claim
$23.62
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 Tri-Estarylla (this brand).

Top reported reactions

Pregnancy On Oral Contraceptive56
Nausea49
Vomiting40
Headache39
Product Quality Issue30
Depression29
Drug Interaction29

Age at onset

Adolescent5
Adult47

Reporter sex

729 reports
Male · 1%
Female · 99%

Serious outcomes

Hospitalization133
Life-threatening26
Death13
Disabling11
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 52 14
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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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.
← 70700-0120-85 · Xiromed, 70700-0122-85 · 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.