Quick answers
- What is Levonorgestrel used for?
- The FDA-approved label (Mirena, Bayer HealthCare Pharmaceuticals Inc., October 29, 2025) says: “Mirena is a progestin-containing intrauterine system (IUS) indicated for: • Prevention of pregnancy for up to 8 years • Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levonorgestrel have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Levonorgestrel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levonorgestrel been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levonorgestrel?
- 3 companies list prescription products of Levonorgestrel in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc., Novel Laboratories, Inc. and Allergan, Inc..
What Levonorgestrel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Mirena is a progestin-containing intrauterine system (IUS) indicated for: • Prevention of pregnancy for up to 8 years • Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. …
— FDA label: Mirena, Bayer HealthCare Pharmaceuticals Inc., effective October 29, 2025. Read the full label on DailyMed →
The FDA has 5 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.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Bayer HealthCare Pharmaceuticals Inc.3 products
- Novel Laboratories, Inc.1 product
- Allergan, 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 |
|---|---|---|---|
| NDA021225 MIRENA | Bayer Hlthcare | December 6, 2000 | 26, latest August 12, 2022 2022: Efficacy · 2021: Efficacy · 2021: Labeling |
| NDA203159 SKYLA | Bayer Hlthcare | January 9, 2013 | 11, latest May 4, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA206229 LILETTA | Medicines360 | February 26, 2015 | 9, latest June 29, 2023 2023: Efficacy · 2022: Labeling · 2022: Efficacy |
| NDA208224 KYLEENA | Bayer Hlthcare | September 16, 2016 | 4, latest May 4, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
Generic approvals (1)
- ANDA202508Novel Labs Inc · February 22, 2013
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) — Mirena, Bayer HealthCare Pharmaceuticals Inc., effective October 29, 2025; 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 →