Quick answers
- What is Levonorgestrel and ethinyl estradiol used for?
- The FDA-approved label (Twirla, Agile Therapeutics, Inc., June 30, 2026) says: “TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA […]. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levonorgestrel and ethinyl estradiol have a boxed warning?
- Yes. The FDA label for Twirla has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levonorgestrel and ethinyl estradiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levonorgestrel and ethinyl estradiol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levonorgestrel and ethinyl estradiol?
- 4 companies list prescription products of Levonorgestrel and ethinyl estradiol in the FDA NDC Directory, including Ingenus Pharmaceuticals, LLC, Glenmark Pharmaceuticals Inc., USA and Agile Therapeutics, Inc..
What Levonorgestrel and ethinyl estradiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA […]. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 […]. …
— FDA label: Twirla, Agile Therapeutics, Inc., effective June 30, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethinyl estradiol 2.3 mg · levonorgestrel 2.6 mg patch | Brand: Twirla | $66.99 per patch |
| ethinyl estradiol 20 ug · levonorgestrel 90 ug tablet | Generic | $1.09 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Ingenus Pharmaceuticals, LLC1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Agile Therapeutics, Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204017 TWIRLA | Agile | February 14, 2020 | 2, latest June 18, 2026 2026: Labeling · 2022: Labeling |
Generic approvals (3)
- ANDA079218Watson Labs · June 6, 2011
- ANDA202791Glenmark Pharms Ltd · April 9, 2015
- ANDA091692Novast Labs · October 22, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Twirla, Agile Therapeutics, Inc., effective June 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →