Prescription medicine
Ethinyl estradiol and levonorgestrel Brand names: Twirla, Tyblume, Balcoltra, Vienva, Jaimiess; first approved as Nordette-21
Ethinyl estradiol and levonorgestrel (Twirla) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.154 per falmina-28 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and levonorgestrel FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.); the NDA 18668 record on Drugs@FDA; every ethinyl estradiol and levonorgestrel label on DailyMed.
Highlights of the record
FDA label of August 27, 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 combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TYBLUME (levonorgestrel and ethinyl estradiol) tablets, are contraindicated in women who are over 35 years of age and smoke [ see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. TYBLUME is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular side effects from combination hormonal contraceptive (CHC) use.
Used for
From the label: indications and usageTYBLUME is indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
- 2.6 mg / 2.3 mg
Kit; tablet; patch.
On the market
- Earliest approval on file
- May 10, 1982 Nordette-21, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 61 first December 13, 1993; 48 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 19 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- August 26, 2028 Twirla system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per tablet Falmina-28 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2012 0 Class I among all firms' recalls; latest March 9, 2020
- FAERS reports
- 3,159 through July 30, 2026
What is ethinyl estradiol and levonorgestrel used for?
From the label: indications and usageTYBLUME is indicated for use by females of reproductive potential to prevent pregnancy. TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
Conditions named in the indications of ethinyl estradiol and levonorgestrel's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen, Progestin and Progestin-containing Intrauterine System.
Source: FDA drug label (Tyblume), Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), via openFDA; the full label on DailyMed
What does the patient leaflet for ethinyl estradiol and levonorgestrel 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 TYBLUME (a type of birth control pill)?Do not use TYBLUME if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control, 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 TYBLUME?Store the blister card that TYBLUME comes in at room temperature between 68°F to 77°F (20°C to 25°C). Protect TYBLUME from light. Protect TYBLUME from high heat. Keep TYBLUME and all medicines out of the reach of children.
Source: FDA drug label (Tyblume), Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and levonorgestrel (Twirla)?
The FDA approved the first generic ethinyl estradiol and levonorgestrel on December 13, 1993. 61 generic applications are approved; 48 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 2 tentative approvals: 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 levonorgestrel from 19 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Twirla system, the last expiring on August 26, 2028; a patent listed only for Quartette tablets runs to March 11, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1982 earliest approval on file
- 1993 first generic approved
- 2028 last listed patent
- 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 levonorgestrel (Twirla)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per Falmina-28 tablet, down 2% from $0.157 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Falmina-28 tablet (generic)
- Balcoltra tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Altavera-28 tablet | Generic | $0.114 per tablet | $3.41 | -0.6% |
| Amethyst 90-20 mcg tablet | Generic | $1.14 per tablet | $34.07 | -10% |
| Ashlyna 0.15-0.03-0.01 mg tablet | Generic | $0.125 per tablet | $3.74 | -32% |
| Aubra eq-28 tablet | Generic | $0.154 per tablet | $4.61 | -2% |
| Aviane-28 tablet | Generic | $0.154 per tablet | $4.61 | -2% |
| Ayuna-28 tablet | Generic | $0.114 per tablet | $3.41 | -0.6% |
| Camrese 0.15-0.03-0.01 mg tablet | Generic | $0.125 per tablet | $3.74 | -32% |
| Camrese lo tablet | Generic | $0.234 per tablet | $7.02 | +9% |
| Chateal eq-28 tablet | Generic | $0.114 per tablet | $3.41 | -0.6% |
| Daysee 0.15-0.03-0.01 mg tablet | Generic | $0.125 per tablet | $3.74 | -32% |
| Dolishale 90-20 mcg tablet | Generic | $1.14 per tablet | $34.07 | -10% |
| Falmina-28 tablet | Generic | $0.154 per tablet | $4.61 | -2% |
| Introvale 0.15-0.03 mg tablet | Generic | $0.227 per tablet | $6.80 | n/a |
| Jaimiess 0.15-0.03-0.01 mg tablet | Generic | $0.125 per tablet | $3.74 | -32% |
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 levonorgestrel been recalled?
The FDA's Enforcement Report lists 9 recalls naming ethinyl estradiol and levonorgestrel since 2012: 0 Class I (the most serious), 1 Class II, 8 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 9, 2020 | Class II | Lupin Pharmaceuticals Inc. | Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. |
| September 18, 2018 | Class III | Xiromed LLC | Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion. |
| August 27, 2018 | Class III | Mylan Pharmaceuticals Inc. | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. |
| March 15, 2013 | Class III | Teva Pharmaceuticals USA, Inc. | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing |
| March 14, 2013 | Class III | Teva Pharmaceuticals USA, Inc. | Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing |
| March 12, 2013 | Class III | Teva Pharmaceuticals USA, Inc. | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. |
| April 23, 2012 | Class III | Teva Pharmaceuticals USA, Inc. | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ethinyl estradiol and levonorgestrel label say about other medicines?
The ethinyl estradiol and levonorgestrel label names 38 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 systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. |
| Aprepitant | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate … |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. |
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity Disorders and Other Vascular Problems |
| Atazanavir | drug interactions | In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine). |
| Atorvastatin | drug interactions | Substances increasing the systemic exposure of CHCs: Co-administration of atorvastatin or rosuvastatin and CHCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. |
| Bosentan | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate … |
| Carbamazepine | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate … |
| Colesevelam | drug interactions | Colesevelam Clinical effect Concomitant use of CHCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol [see Clinical Pharmacology (12.3) ]. |
| Cyclosporine | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Darunavir | drug interactions | Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g. … |
| Efavirenz | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate … |
| Etravirine | drug interactions | In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine). |
| Felbamate | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate … |
Every other medicine the ethinyl estradiol and levonorgestrel label names
| Medicine named | Section | What the label says |
|---|---|---|
| Fluconazole | drug interactions | CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice The effect of grapefruit juice on CYP3A4 enzymes (e.g., strong vs. … |
| Griseofulvin | drug interactions | … Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products … |
| Itraconazole | drug interactions | CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice The effect of grapefruit juice on CYP3A4 enzymes (e.g., strong vs. … |
| Ketoconazole | drug interactions | … inhibition) depends on its brand, concentration, and preparation. , or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of CHCs. |
| Lamotrigine | drug interactions | Clinical effect; Concomitant use of CHCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation [see ]. … |
| Lopinavir and ritonavir | drug interactions | Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir … |
| Morphine | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Nelfinavir | drug interactions | … CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV … |
| Nevirapine | drug interactions | … telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine). |
| Oxcarbazepine | drug interactions | … barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. … |
| Phenytoin | drug interactions | … carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. … |
| Prednisolone | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Primidone | drug interactions | … efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. … |
| Rifabutin | drug interactions | … griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. … |
| Rifampin | drug interactions | … carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. … |
| Ritonavir | contraindications | … of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.14) ] High risk of … |
| Rosuvastatin | drug interactions | Substances increasing the systemic exposure of CHCs: Co-administration of atorvastatin or rosuvastatin and CHCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by … |
| Rufinamide | drug interactions | … oxcarbazepine, phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. John's wort, and certain protease inhibitors (see separate section on … |
| Salicylic acid | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Temazepam | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Theophylline | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Tizanidine | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Topiramate | drug interactions | … phenytoin, rifampin, primidone, phenylbutazone, rifabutin, rufinamide, topiramate, products containing St. John's wort, and certain protease inhibitors (see separate section on protease inhibitors … |
| Voriconazole | drug interactions | CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice The effect of grapefruit juice on CYP3A4 enzymes (e.g., strong vs. … |
Check ethinyl estradiol and levonorgestrel against other medicines
Source: FDA drug label (Tyblume), Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and levonorgestrel?
The FDA Adverse Event Reporting System holds 3,159 reports that list ethinyl estradiol and levonorgestrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 40 are coded as a death and 557 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
What else is labeled for the same conditions as ethinyl estradiol and levonorgestrel?
2 other medicines are given the same way (oral) and in the same FDA class as ethinyl estradiol and levonorgestrel or labeled mainly for the same use (birth control), the same class first. Birth control lists all 24 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Norethindrone | Birth control | 17 labelers | $0.290 per tablet 5 mg tablet | No current entry |
| Ulipristal | Birth control | none listed | $37.10 per tablet 30 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ethinyl estradiol and levonorgestrel compare with medicines for the same use?
3 side-by-side pages set ethinyl estradiol and levonorgestrel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Ethinyl estradiol and levonorgestrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other