Prescription medicine
Ethinyl estradiol and norgestimate Brand names: Mono-Linyah, Sprintec, Tri-Lo-Marzia, Tri-Sprintec, Estarylla; first approved as Ortho Cyclen-28
Ethinyl estradiol and norgestimate (Sprintec) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.115 per mili 0.25-0.035 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norgestimate FDA label on DailyMed (effective February 6, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 19653 record on Drugs@FDA; every ethinyl estradiol and norgestimate label on DailyMed.
Highlights of the record
FDA label of February 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning.
Norgestimate and ethinyl estradiol tablets are contraindicated in women over 35 years old who smoke. ( 4 )
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.
Used for
From the label: indications and usageNorgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- December 29, 1989 Ortho Cyclen-28, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 32 first September 25, 2002; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 18 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.115 per tablet Mili 0.25-0.035 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2020 0 Class I among all firms' recalls; latest September 2, 2025
- FAERS reports
- 4,557 through July 30, 2026
What is ethinyl estradiol and norgestimate used for?
From the label: indications and usageNorgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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. […]
Conditions named in the indications of ethinyl estradiol and norgestimate's FDA labels, with every medicine labeled for each:
From other ethinyl estradiol and norgestimate labelsAcne: … 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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 […]
Source: FDA drug label (Norgestimate and Ethinyl Estradiol), Glenmark Pharmaceuticals Inc., USA, effective February 6, 2026 (SPL set 8b247e46-203e-4f5b-b5a7-cbd57341c735), via openFDA; the full label on DailyMed
What does the patient leaflet for ethinyl estradiol and norgestimate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about norgestimate and ethinyl estradiol tablets?Do not use norgestimate and ethinyl estradiol tablets 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.
From the patient leaflet: How should I store norgestimate and ethinyl estradiol tablets?Store norgestimate and ethinyl estradiol tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Keep norgestimate and ethinyl estradiol tablets and all medicines out of the reach of children. • Store away from light.
Source: FDA drug label (Norgestimate and Ethinyl Estradiol), Glenmark Pharmaceuticals Inc., USA, effective February 6, 2026 (SPL set 8b247e46-203e-4f5b-b5a7-cbd57341c735), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and norgestimate (Sprintec)?
The FDA approved the first generic ethinyl estradiol and norgestimate on September 25, 2002. 32 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ethinyl estradiol and norgestimate from 18 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethinyl estradiol and norgestimate (Sprintec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.115 per Mili 0.25-0.035 mg tablet, down 10% from $0.128 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tri-lo-mili tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Estarylla 0.25-0.035 mg tablet | Generic | $0.115 per tablet | $3.44 | -10% |
| Mili 0.25-0.035 mg tablet | Generic | $0.115 per tablet | $3.44 | -10% |
| Mono-linyah 28 tablet | Generic | $0.115 per tablet | $3.44 | -10% |
| Norg-ee 0.18-0.215-0.25/0.035 | Generic | $0.126 per unit | n/a | -8% |
| Norg-ethin estra 0.25-0.035 mg | Generic | $0.115 per unit | n/a | -10% |
| Sprintec 28 day tablet | Generic | $0.115 per tablet | $3.44 | -10% |
| Tri-estarylla tablet | Generic | $0.126 per tablet | $3.79 | -8% |
| Tri-linyah tablet | Generic | $0.126 per tablet | $3.79 | -8% |
| Tri-lo-estarylla tablet | Generic | $0.108 per tablet | $3.24 | -4% |
| Tri-lo-marzia tablet | Generic | $0.108 per tablet | $3.24 | -4% |
| Tri-lo-mili tablet | Generic | $0.108 per tablet | $3.24 | -4% |
| Tri-lo-sprintec tablet | Generic | $0.108 per tablet | $3.24 | -4% |
| Tri-mili 28 tablet | Generic | $0.126 per tablet | $3.79 | -8% |
| Tri-sprintec tablet | Generic | $0.126 per tablet | $3.79 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ethinyl estradiol and norgestimate been recalled?
The FDA's Enforcement Report lists 3 recalls naming ethinyl estradiol and norgestimate since 2020: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 2, 2025 | Class II | AvKARE | Failed Content Uniformity Specifications |
| March 7, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| January 10, 2020 | Class III | Lupin Pharmaceuticals Inc. | CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ethinyl estradiol and norgestimate label say about other medicines?
The ethinyl estradiol and norgestimate label names 35 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Aprepitant | drug interactions | 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. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Atazanavir | drug interactions | … (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 … |
| Atorvastatin | drug interactions | Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%. |
| Bosentan | drug interactions | 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. |
| Carbamazepine | drug interactions | 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. |
| Cobicistat | drug interactions | … nevirapine] or increase [e.g., etravirine]) or with HIV/AIDS medications containing strong inhibitors (e.g., cobicistat and ritonavir) or inducers of CYP3A. |
| Colesevelam | drug interactions | Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. |
| Cyclosporine | drug interactions | COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Darunavir | drug interactions | … 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 … |
| Etravirine | drug interactions | … 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. |
| Felbamate | drug interactions | 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. |
| Fluconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Every other medicine the ethinyl estradiol and norgestimate label names
| Medicine named | Section | What the label says |
|---|---|---|
| Griseofulvin | drug interactions | … include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Itraconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Lamotrigine | drug interactions | COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Lopinavir and ritonavir | drug interactions | 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 … |
| Morphine | drug interactions | COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Nelfinavir | drug interactions | … of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase … |
| Nevirapine | drug interactions | … 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 … |
| Oxcarbazepine | drug interactions | … phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine … |
| Prednisolone | drug interactions | COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Rifabutin | drug interactions | … bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Ritonavir | contraindications | 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 )] |
| Rosuvastatin | drug interactions | 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 … |
| Rufinamide | drug interactions | … felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Salicylic acid | drug interactions | COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Temazepam | drug interactions | COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Theophylline | drug interactions | COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Tizanidine | drug interactions | COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Voriconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Check ethinyl estradiol and norgestimate against other medicines
Source: FDA drug label (Norgestimate and Ethinyl Estradiol), Glenmark Pharmaceuticals Inc., USA, effective February 6, 2026 (SPL set 8b247e46-203e-4f5b-b5a7-cbd57341c735), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and norgestimate?
The FDA Adverse Event Reporting System holds 4,557 reports that list ethinyl estradiol and norgestimate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 672 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does ethinyl estradiol and norgestimate compare with medicines for the same use?
1 side-by-side page set ethinyl estradiol and norgestimate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Ethinyl estradiol and norgestimate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other