Drug
Who makes levonorgestrel?
3 companies list levonorgestrel as a human prescription drug, including under the names Kyleena, LILETTA, Mirena, Skyla. Forms: intrauterine device; tablet. Routes: intrauterine, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing levonorgestrel
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bayer Healthcare Manufacturing SrlGermany | intrauterine device | NDANDA021225, NDA203159, NDA208224 | 3 | 13 |
| Allergan, Inc.United States | intrauterine device | NDANDA206229 | 1 | 7 |
| Novel Laboratories IncUnited States | tablet | ANDAANDA202508 | 1 | 1 |
Bulk ingredient listings
- Industriale Chimica SRLItaly · 3 NDC
- Gedeon Richter Plc.Hungary · 2 NDC
- Hubei Gedian Humanwell Pharmaceutical Co., LtdChina · 2 NDC
- Qinhuangdao Zizhu Pharmaceutical Co LtdChina · 2 NDC
- Sterling Chemical Malta LtdMalta · 2 NDC
- Bayer Healthcare Manufacturing SrlGermany · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Formosa Laboratories, Inc.Taiwan · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
- Zhejiang Xianju Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
7 unexpired patents list levonorgestrel as the active ingredient, expiring between Feb 2027 and Sept 2040. Application holders: BAYER HEALTHCARE PHARMACEUTICALS INC, MEDICINES360.
Enquiry
Common questions
- Who makes levonorgestrel?
- 3 companies list levonorgestrel as a human prescription drug in the openFDA NDC Directory, led by Bayer Healthcare Manufacturing Srl, Allergan, Inc., Novel Laboratories Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Kyleena?
- 1 company lists levonorgestrel under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies levonorgestrel active ingredient?
- 13 companies list levonorgestrel as a bulk ingredient, including Industriale Chimica SRL, Gedeon Richter Plc., Hubei Gedian Humanwell Pharmaceutical Co., Ltd, Qinhuangdao Zizhu Pharmaceutical Co Ltd.