Home › NDC Lookup › Ingredients › Norgestimate And Ethinyl Estradiol › 68180-0837-73
📦image loading
(from DailyMed)

TRI-LO-MARZIA norgestimate and ethinyl estradiol Kit, 3 pouches — NDC 68180-837-73 (Billing 68180-0837-73)

by Lupin Pharmaceuticals, Inc. · 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

This is a package of 3 pouches of TRI-LO-MARZIA norgestimate and ethinyl estradiol Kit from Lupin Pharmaceuticals, Inc., marketed since Jan 2020 and currently FDA-listed; retail pharmacies pay about $0.1080 per pouche (NADAC). It is this product's only package size.

NDC 68180-0837-73
🏷️ FDA NDC (as labeled) 68180-837-73 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) 68180-837-73
Product NDC 68180-837
11-digit billing NDC 68180083773
NCPDP billing unit EA — each (per item)
RxCUI 578732, 748797, 749155, 749156, 749157, 1305757
UPC 0368180837718
Application # ANDA200541
SPL Set ID bc402baa-5de4-4149-9857-081a9b4eb280
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-08
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 25992002300310
GPI class Tri-Lo-Marzia
GCN Seq No 050831
GCN 18126
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-LO-MARZIA TABLET
FDB brand name Tri-Lo-Marzia
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 050831
  • GCN: 18126
  • GPI-14 (Medi-Span): 25992002300310
  • HICL (First Databank): 004845
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 578732
Why two NDCs? The FDA registers this code as 68180-837-73 — 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 → 68180-0837-73. 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-LO-MARZIA 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 $0.108 $0.32 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.3008 $0.90 / 3 kit
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.178 $0.105
▼ Down 39% 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
68180-0837-73 You're viewing this Main listing 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2020-01-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tri-Lo-Sprintec 00093-2140-62 Teva 3 pouches $0.108 AB Availability likely —
Tri-Lo-Mili 65862-0778-28 Aurobindo 1 kit $0.108 AB Availability likely —
Tri-VyLibra Lo 50102-0231-13 Afaxys 1 kit $0.108 AB Availability likely —
Tri-Lo- Estarylla 70700-0120-85 Xiromed, 1 kit $0.108 AB Availability likely —
Tri-Lo-Marziathis 68180-0837-73 Lupin 3 pouches $0.108 AB Availability likely —
Estarylla 70700-0119-85 Xiromed, 1 kit $0.115 AB Availability likely +6%
Sprintec 00555-9016-58 Teva 6 pouches $0.115 AB Availability likely +6%
VyLibra 50102-0235-11 Afaxys 1 kit $0.115 AB Availability likely +6%
Mono-Linyah 16714-0360-01 Northstar 1 packet $0.115 AB Availability likely +6%
Mili 65862-0776-28 Aurobindo 1 kit $0.115 AB Availability likely +6%
Norgestimate and Ethinyl Estradiol 68462-0309-29 Glenmark 1 kit $0.115 AB Availability likely +6%
Norgestimate and Ethinyl Estradiol 68180-0840-73 Lupin 3 pouches $0.115 AB Availability likely +6%
Tri-Mili 65862-0777-28 Aurobindo 1 kit $0.126 AB Availability likely +17%
Tri-Estarylla 70700-0121-85 Xiromed, 1 kit $0.126 AB Availability likely +17%
Norgestimate and Ethinyl Estradiol 68462-0565-29 Glenmark 1 kit $0.126 AB Availability likely +17%
Tri-Sprintec 00555-9018-58 Teva 6 pouches $0.126 AB Availability likely +17%
Norgestimate and ethinyl estradiol 68180-0838-73 Lupin 1 kit $0.126 AB Availability likely +17%
Tri-VyLibra 50102-0233-11 Afaxys 1 kit $0.126 AB Availability likely +17%
Tri-Linyah 16714-0363-01 Northstar 1 packet $0.126 AB Availability likely +17%
Nymyo 51862-0645-01 Mayne 1 packet $0.135 AB FDA listed +25%
Tri-Nymyo 51862-0646-01 Mayne 1 packet $0.140 AB FDA listed +29%
Tri Femynor 69238-1607-06 Amneal 1 kit $0.140 — FDA listed +29%
Femynor 69238-1551-06 Amneal 1 kit $0.144 — FDA listed +34%
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN PHARMACEUTICALS INC
FDA applicationANDA200541 (ANDA)
Labeler code68180
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio404 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 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 111 words ▾

WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Tri-Lo-Marzia 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 ) 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 )].

🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 )

1.1Oral Contraception Tri-Lo-Marzia™ Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14 )].

⏱️ Dosage and Administration ~3 min read ▾

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

2.1How to Start Tri-Lo-Marzia Tri-Lo-Marzia is dispensed in a blister [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )]. Tri-Lo-Marzia may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

2.2How to Take Tri-Lo-Marzia Table 1 : Instructions for Administration of Tri - Lo - Marzia 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 : ο Tri-Lo-Marzia active tablets are white to off white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21) and has green inactive tablets ( Day 22 to Day 28) Day 1 Start : ο Take first active tablet without regard to meals on the first day of menses. ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. ο Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start : ο 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 - Lo - Marzia . ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. ο 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 - Lo - Marzia 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 - Lo - Marzia Start Tri - Lo - Marzia : ο Transdermal patch ο On the day when next application would have been scheduled ο Vaginal ring ο On the day when next insertion would have been scheduled ο Injection ο On the day when next injection would have been scheduled ο Intrauterine contraceptive ο On the day of removal ο 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. ο Implant ο 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-Lo-Marzia after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage, Tri-Lo-Marzia may be started immediately. An additional method of contraception is not needed if Tri-Lo-Marzia is started immediately. If Tri-Lo-Marzia 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 pack of Tri-Lo-Marzia.

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-Lo-Marzia, 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 pa… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 197 words ▾

3 DOSAGE FORMS AND STRENGTHS Tri-Lo-Marzia consists of 28 round, film-coated tablets in the following order ( 3 ): 7 white to off white tablets each containing 0.18 mg norgestimate and 0.025 mg ethinyl estradiol 7 light blue tablets each containing 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 blue tablets each containing 0.25 mg norgestimate and 0.025 mg ethinyl estradiol 7 green tablets (inert) Tri-Lo-Marzia Tablets are available in a blister. Each blister contains 28 tablets in the following order: 7 white to off white, round, film-coated tablets debossed with 'LU' on one side and "E21" on the other side of the tablet contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol 7 light blue, round, film-coated tablets debossed with 'LU' on one side and "E22" on the other side of the tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 blue, round, film-coated tablets debossed with 'LU' on one side and "E23" on the other side of the tablet contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol 7 green, round, biconvex, film-coated, tablets debossed with 'LU' on one side and "E24" on the other side of the tablet contains inert ingredients

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Tri-Lo-Marzia 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: o Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 )] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS ( 5.1 )] o Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.4 )] o Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.6 )] o Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS ( 5.7 )] o 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 )]

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems: Stop Tri-Lo-Marzia 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 Tri-Lo-Marzia if jaundice occurs. ( 5.2 ) High Blood Pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Tri-Lo-Marzia if blood pressure rises significantly. ( 5.4 ) Carbohydrate and Lipid Metabolic Effects: Monitor prediabetic and diabetic women taking Tri-Lo-Marzia.

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

( 5.8 )

5.1Thromboembolic Disorders and Other Vascular Problems Stop Tri-Lo-Marzia if an arterial thrombotic event or venous thrombotic (VTE) event occurs. Stop Tri-Lo-Marzia 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 Tri-Lo-Marzia 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 Tri-Lo-Marzia no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years.

The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors.

5.2Liver Disease Impaired Liver Function Do not use Tri-Lo-Marzia 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 Tri-Lo-Marzia if jaundice develops.

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

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

5.3Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications,… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, nausea/vomiting, breast issues, abdominal pain, menstrual disorders, mood disorders, acne, vulvovaginal infection, abdominal distension, weight increased, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS ( 5.1 )] Vascular events [see WARNINGS AND PRECAUTIONS ( 5.1 )] Liver disease [see WARNINGS AND PRECAUTIONS ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache

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 Tri-Lo-Marzia was evaluated in 1,723 subjects who participated in a randomized, partially blinded, multicenter, active-controlled clinical trial of Tri-Lo-Marzia for contraception. This trial examined healthy, nonpregnant, volunteers aged 18 to 45 (nonsmoker if 35 to 45 years of age), who were sexually active with regular coitus.

Subjects were followed for up to 13 28-day cycles. Common Adverse Reactions (≥ 2% of subjects) The most common adverse reactions reported by at least 2% of the 1,723 women using the 28-day regimen were the following in order of decreasing incidence: headache/migraine (30.5%), nausea/vomiting (16.3%); breast issues (including tenderness, pain, enlargement, swelling, discharge, discomfort, cyst, and nipple pain) (10.3%), abdominal pain (9.2%), menstrual disorders (including dysmenorrhea, menstrual discomfort, menstrual disorder) (9.2%), mood disorders (including depression, mood altered, mood swings and depressed mood) (7.6%); acne (5.1%), vulvovaginal infection (3.5%), abdominal distension (2.8%), weight increased (2.4%), fatigue (2.1%).

Adverse Reactions Leading to Study Discontinuation In the clinical trial of Tri-Lo-Marzia 4% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were headache/migraine (1.2%), nausea/vomiting (0.7%), cervical dysplasia (0.7%), abdominal pain (0.4%), ovarian cyst (0.3%), acne (0.2%), flatulence (0.2%) and depression (0.2%). Serious Adverse Reactions Carcinoma of the cervix in situ (1 subject) and cervical dysplasia (1 subject).

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 drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported volu… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS 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 ) 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 Tri-Lo-Marzia.

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 COCs include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant and products containing St.

John's wort. Interactions between COCs 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 ethinyl estradiol (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 EE increase AUC values for EE by approximately 20 to 25%.

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

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

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

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

7.4Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~1 min read ▾

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

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

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

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

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

8.5Geriatric Use Tri-Lo-Marzia has not been studied in postmenopausal women and is not indicated in this population.

8.6Hepatic Impairment The pharmacokinetics of Tri-Lo-Marzia 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 Tri-Lo-Marzia has not been studied in women with renal impairment.

🤰 Pregnancy 82 words ▾

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

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

🧒 Pediatric Use 48 words ▾

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

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use Tri-Lo-Marzia 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 overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

🧬 Clinical Pharmacology ~4 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 Tri-Lo-Marzia.

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 NGM. Mean pharmacokinetic parameters for NGMN, NG and EE during three cycles of administration of Tri-Lo-Marzia are summarized in Table 3.

Peak serum concentrations of NGMN and EE were generally reached by 2 hours after administration of Tri-Lo-Marzia. Accumulation following multiple dosing of the 0.18 mg NGM / 0.025 mg EE dose is approximately 1.5 to 2 fold for NGMN and approximately 1.5 fold for EE compared with single dose administration, in agreement with that predicted based on linear kinetics of NGMN and EE. The pharmacokinetics of NGMN is dose proportional following NGM doses of 0.18 to 0.25 mg.

Steady-state conditions for NGMN following each NGM dose and for EE were achieved during the three cycle study. Non-linear accumulation (4.5 to 14.5 fold) of NG was observed as a result of high affinity binding to SHBG, which limits its biological activity. Table 3 Summary of NGMN, NG and EE pharmacokinetic parameters.

Table 3: Mean (SD) Pharmacokinetic Parameters of Tri-Lo-Marzia During a Three Cycle Study NC = not calculated Analyte NGMN = Norelgestromin, NG = norgestrel, EE = ethinyl estradiol Cycle Day C m a x t m a x ( h ) AUC 0 t o 2 4 h t 1 / 2 ( h ) NGMN ( C m a x = peak serum concentration, t m a x = time to reach peak serum concentration, AUC 0 t o 2 4 h = area under serum concentration vs. time curve from 0 to 24 hours, t 1 / 2 = elimination half-life. t o units for NGMN and NG - C m a x = ng/mL, AUC 0 t o 2 4 h = h.ng/mL ) 1 1 0 .

91 (0.27) 1 . 8 (1.0) 5 . 86 (1.54) NC 3 7 1 .

42 (0.43) 1 . 8 (0.7) 11 . 3 (3.2) NC 14 1 .

57 (0.39) 1 . 8 (0.7) 13 . 9 (3.7) NC 21 1 .

82 (0.54) 1 . 5 (0.7) 16 . 1 (4.8) 28 .

1 ( 10 . 6 ) NG ( t o ) 1 1 0 . 32 (0.14) 2 .

0 (1.1) 2 . 44 (2.04) NC 3 7 1 . 64 (0.89) 1 .

9 (0.9) 27 . 9 (18.1) NC 14 2 . 11 (1.13) 4 .

0 (6.3) 40 . 7 (24.8) NC 21 2 . 79 (1.42) 1 .

7 (1.2) 49 . 9 (27.6) 36 . 4 ( 10 .

2 ) EE ( , units for all analytes; h = hours , units for EE only - C m a x = pg/mL, AUC 0 t o 2 4 h = h.pg/mL ) 1 1 55 . 6 (18.1) 1 . 7 (0.5) 421 (118) NC 3 7 91 .

1 (36.7) 1 . 3 (0.3) 782 (329) NC 14 96 . 9 (38.5) 1 .

3 (0.3) 796 (273) NC 21 95 . 9 (38.9) 1 . 3 (0.6) 771 (303) 17 .

7 ( 4 . 4 ) Food Effect: The effect of food on the pharmacokinetics of Tri-Lo-Marzia 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 Following 3 cycles of administration of Tri-Lo-Marzia, the mean (± SD) elimination half-life values, at steady-state, for… [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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tri-Lo-Marzia are available in a blister (NDC 68180-837-71) containing 28 tablets packed in a pouch (NDC 68180-837-71). Such three pouches are packaged in a carton (NDC 68180-837-73). Each blister (28 tablets) contains in the following order: 7 white to off white, round, film-coated tablets debossed with 'LU' on one side and "E21" on the other side contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol 7 light blue, round, film-coated tablets debossed with 'LU' on one side and "E22" on the other side contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 blue, round, film-coated tablets debossed with 'LU' on one side and "E23" on the other side contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol 7 green, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with 'LU' on one side and "E24" on the other side contains inert ingredients

16.2Storage Conditions Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Protect from light. Keep this and all medication out of reach of children.

16.1How Supplied Tri-Lo-Marzia are available in a blister (NDC 68180-837-71) containing 28 tablets packed in a pouch (NDC 68180-837-71). Such three pouches are packaged in a carton (NDC 68180-837-73). Each blister (28 tablets) contains in the following order: 7 white to off white, round, film-coated tablets debossed with 'LU' on one side and "E21" on the other side contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol 7 light blue, round, film-coated tablets debossed with 'LU' on one side and "E22" on the other side contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 blue, round, film-coated tablets debossed with 'LU' on one side and "E23" on the other side contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol 7 green, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with 'LU' on one side and "E24" on the other side contains inert ingredients

📋 Description 185 words ▾

11 DESCRIPTION Tri-Lo-Marzia is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as ((+)-13-Ethyl-17-hydroxy-18, 19-dinor-17a-pregn-4-en-20-yn-3-one oxime acetate (ester)) and ethinyl estradiol is designated as (19-nor-17a-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white film-coated tablet contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol.

Inactive ingredients include anhydrous lactose, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each active light blue film-coated tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No.

2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each active blue film-coated tablet contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No.

2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each green film-coated tablet contains only inert ingredients, as follows: croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

Image structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-APPROVED PATIENT LABELING (PATIENT INFORMATION and INSTRUCTION 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-Lo-Marzia does not protect against HIV infection (AIDS) and other sexually transmitted infections. Tri-Lo-Marzia is not to be used during pregnancy; if pregnancy occurs during use of Tri-Lo-Marzia instruct the patient to stop further use [see WARNINGS AND PRECAUTIONS ( 5.9 )]. Take one tablet daily by mouth at the same time every day.

Instruct patients what to do in the event tablets are missed [see DOSAGE AND ADMINISTRATION ( 2.2 )]. Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-Lo-Marzia [see DRUG INTERACTIONS ( 7.1 )]. COCs may reduce breast milk production, this is less likely to occur if breastfeeding is well established [see USE IN SPECIFIC POPULATIONS ( 8.3 )].

Women who start COCs postpartum; and who have not yet had a period, should use an additional method of contraception until they have taken a white tablet for 7 consecutive days [see DOSAGE AND ADMINISTRATION ( 2.2 )]. Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period.

Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see WARNINGS AND PRECAUTIONS ( 5.8 )]. Distributed by: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India Revised: November 2024 image

🍼 Nursing Mothers 62 words ▾

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

🧬 Pharmacokinetics ~4 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 NGM. Mean pharmacokinetic parameters for NGMN, NG and EE during three cycles of administration of Tri-Lo-Marzia are summarized in Table 3.

Peak serum concentrations of NGMN and EE were generally reached by 2 hours after administration of Tri-Lo-Marzia. Accumulation following multiple dosing of the 0.18 mg NGM / 0.025 mg EE dose is approximately 1.5 to 2 fold for NGMN and approximately 1.5 fold for EE compared with single dose administration, in agreement with that predicted based on linear kinetics of NGMN and EE. The pharmacokinetics of NGMN is dose proportional following NGM doses of 0.18 to 0.25 mg.

Steady-state conditions for NGMN following each NGM dose and for EE were achieved during the three cycle study. Non-linear accumulation (4.5 to 14.5 fold) of NG was observed as a result of high affinity binding to SHBG, which limits its biological activity. Table 3 Summary of NGMN, NG and EE pharmacokinetic parameters.

Table 3: Mean (SD) Pharmacokinetic Parameters of Tri-Lo-Marzia During a Three Cycle Study NC = not calculated Analyte NGMN = Norelgestromin, NG = norgestrel, EE = ethinyl estradiol Cycle Day C m a x t m a x ( h ) AUC 0 t o 2 4 h t 1 / 2 ( h ) NGMN ( C m a x = peak serum concentration, t m a x = time to reach peak serum concentration, AUC 0 t o 2 4 h = area under serum concentration vs. time curve from 0 to 24 hours, t 1 / 2 = elimination half-life. t o units for NGMN and NG - C m a x = ng/mL, AUC 0 t o 2 4 h = h.ng/mL ) 1 1 0 .

91 (0.27) 1 . 8 (1.0) 5 . 86 (1.54) NC 3 7 1 .

42 (0.43) 1 . 8 (0.7) 11 . 3 (3.2) NC 14 1 .

57 (0.39) 1 . 8 (0.7) 13 . 9 (3.7) NC 21 1 .

82 (0.54) 1 . 5 (0.7) 16 . 1 (4.8) 28 .

1 ( 10 . 6 ) NG ( t o ) 1 1 0 . 32 (0.14) 2 .

0 (1.1) 2 . 44 (2.04) NC 3 7 1 . 64 (0.89) 1 .

9 (0.9) 27 . 9 (18.1) NC 14 2 . 11 (1.13) 4 .

0 (6.3) 40 . 7 (24.8) NC 21 2 . 79 (1.42) 1 .

7 (1.2) 49 . 9 (27.6) 36 . 4 ( 10 .

2 ) EE ( , units for all analytes; h = hours , units for EE only - C m a x = pg/mL, AUC 0 t o 2 4 h = h.pg/mL ) 1 1 55 . 6 (18.1) 1 . 7 (0.5) 421 (118) NC 3 7 91 .

1 (36.7) 1 . 3 (0.3) 782 (329) NC 14 96 . 9 (38.5) 1 .

3 (0.3) 796 (273) NC 21 95 . 9 (38.9) 1 . 3 (0.6) 771 (303) 17 .

7 ( 4 . 4 ) Food Effect: The effect of food on the pharmacokinetics of Tri-Lo-Marzia 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 Following 3 cycles of administration of Tri-Lo-Marzia, the mean (± SD) elimination half-life values, at steady-state, for NGMN, NG and EE were 28.1 (± 10.6) hours, 36.4 (± 10.2) hours and 17.7 (± 4.4) hours, respectively (Table 2). The metabolites of NGMN and EE are eliminated by renal and fecal pathways.

Use in Specific Populations Effects of Body Weight, Body Surface Area, and Age: The effects of body weight, body surface area, age and race on the pharmacokinetics of NGMN, NG and EE were evaluat… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Tri-Lo-Marzia.

🔬 Clinical Studies 101 words ▾

14 CLINICAL STUDIES In an active controlled clinical trial lasting 12 months, 1,673 women, 18 to 45 years old completed 11,003 cycles of Tri-Lo-Marzia use and a total of 20 pregnancies were reported in Tri-Lo-Marzia users. The racial demographic of those treated with Tri-Lo-Marzia was: Caucasian (86%), African-American (6%), Asian (2%), and Other (6%). There were no exclusions on the basis of weight; the weight range for women treated was 90 to 240 lbs, with a mean weight of about 142 lbs.

The pregnancy rate in women aged 18 to 35 years was approximately 2.6 pregnancies per 100 woman-years of use.

🧪 Nonclinical Toxicology 26 words ▾

13 NONCLINICAL TOXICOLOGY

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

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Tri-Lo-Marzia™ [TRY-LOW-mar-ZEE-uh] (norgestimate and ethinyl estradiol tablets USP) What is the most important information I should know about Tri-Lo-Marzia? Do not use Tri-Lo-Marzia 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-Lo-Marzia? Tri-Lo-Marzia is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Tri-Lo-Marzia 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 from the clinical study, about 3 out of 100 women may get pregnant during the first year they use Tri-Lo-Marzia. 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-Lo-Marzia?

Do not take Tri-Lo-Marzia 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 or any cancer that is sensitive to female hormones If any of these conditions happen while you are taking Tri-Lo-Marzia, stop taking Tri-Lo-Marzia right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri-Lo-Marzia. What should I tell my healthcare provider before taking Tri-Lo-Marzia?

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

Read the Instructions for Use at the end of this Patient Information. What are the possible serious side effects of Tri-Lo-Marzia? Like pregnancy, Tri-Lo-Marzia 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… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

RECENT MAJOR CHANGES Warnings and Precautions ( 5.11 ) 12/2021

📄 Package Label / Principal Display Panel 97 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP) 0.18 mg 0.025 mg, 0.215 mg 0.025 mg, 7 0.25 mg 0.025 mg 28 Day Regimen Blister Pack: NDC: 68180-837-71 28 Tablets TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP) 0.18 mg 0.025 mg, 0.215 mg 0.025 mg, 7 0.25 mg 0.025 mg 28 Day Regimen Pouch: NDC: 68180-837-71 28 Tablets TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP) 0.18 mg 0.025 mg, 0.215 mg 0.025 mg, 7 0.25 mg 0.025 mg 28 Day Regimen Carton Pack: NDC: 68180-837-73 3 Blisters of 28 Tablets Each wallet pouch carton

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 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
61.4K
Units reimbursed last 4 qtrs
3.3M
Gross reimbursed last 4 qtrs
$977.6K
Avg / prescription
$15.91
Avg / unit
$0.3008
Latest quarter Q4 2025
13.9KRx
Medicaid pays / ea
$0.3008
gross reimbursed
vs
NADAC / ea
$0.1080
acquisition cost
=
Spread
+$0.1928
+179% 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 ⓘ
36% FFS 64% MCO
Fee-for-service · 22,022 Rx Managed care · 39,405 Rx
State Medicaid map
Alaska: 3,416 units · 466 per 100k residents AK Maine: 1,764 units · 126 per 100k residents ME Washington: 82,292 units · 1,053 per 100k residents WA Idaho: 9,660 units · 492 per 100k residents ID Montana: 10,500 units · 928 per 100k residents MT North Dakota: 3,192 units · 408 per 100k residents ND Minnesota: 43,624 units · 760 per 100k residents MN Wisconsin: 39,424 units · 667 per 100k residents WI Michigan: 75,156 units · 749 per 100k residents MI New York: 563,438 units · 2,879 per 100k residents NY Vermont: 5,320 units · 822 per 100k residents VT New Hampshire: 11,816 units · 843 per 100k residents NH Oregon: 71,825 units · 1,697 per 100k residents OR Nevada: 10,472 units · 328 per 100k residents NV Wyoming: 3,808 units · 652 per 100k residents WY South Dakota: 3,276 units · 356 per 100k residents SD Iowa: 13,328 units · 416 per 100k residents IA Illinois: 106,848 units · 851 per 100k residents IL Indiana: 204,932 units · 2,986 per 100k residents IN Ohio: 122,148 units · 1,036 per 100k residents OH Pennsylvania: 268,100 units · 2,069 per 100k residents PA New Jersey: 87,808 units · 945 per 100k residents NJ Massachusetts: 141,064 units · 2,015 per 100k residents MA California: 127,831 units · 328 per 100k residents CA Utah: 8,624 units · 252 per 100k residents UT Colorado: 76,496 units · 1,301 per 100k residents CO Nebraska: 10,808 units · 546 per 100k residents NE Missouri: 43,316 units · 699 per 100k residents MO Kentucky: 81,822 units · 1,808 per 100k residents KY West Virginia: 62,944 units · 3,556 per 100k residents WV Virginia: 94,920 units · 1,089 per 100k residents VA Maryland: 108,472 units · 1,755 per 100k residents MD Connecticut: 96,236 units · 2,661 per 100k residents CT Rhode Island: 27,188 units · 2,483 per 100k residents RI Arizona: 40,124 units · 540 per 100k residents AZ New Mexico: 15,316 units · 725 per 100k residents NM Kansas: 6,440 units · 219 per 100k residents KS Arkansas: 26,516 units · 865 per 100k residents AR Tennessee: 54,292 units · 762 per 100k residents TN North Carolina: 193,452 units · 1,785 per 100k residents NC South Carolina: 48,104 units · 895 per 100k residents SC Delaware: 9,380 units · 910 per 100k residents DE Oklahoma: 27,916 units · 689 per 100k residents OK Louisiana: 33,292 units · 728 per 100k residents LA Mississippi: 31,444 units · 1,070 per 100k residents MS Alabama: 22,484 units · 440 per 100k residents AL Georgia: 62,636 units · 568 per 100k residents GA D.C.: 8,512 units · 1,254 per 100k residents DC Hawaii: no data reported HI Texas: 42,648 units · 140 per 100k residents TX Florida: 5,964 units · 26.4 per 100k residents FL
Units reimbursed · per 100k residents
26.43,556
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 West Virginia 3,556 /100k
2 Indiana 2,986 /100k
3 New York 2,879 /100k
4 Connecticut 2,661 /100k
5 Rhode Island 2,483 /100k
6 Pennsylvania 2,069 /100k
7 Massachusetts 2,015 /100k
8 Kentucky 1,808 /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-Lo-Marzia — 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-Lo-Marzia. 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
$18.3K
Claims incl. refills
748
Beneficiaries
499
Spend / beneficiary
$36.64
Spend / claim
$24.44
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

Kit / multi-component package

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

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

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lupin Pharmaceuticals, Inc. 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.
← 68180-0828-73 · Lupin 68180-0838-73 · Lupin →
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.