Active ingredient
Levonorgestrel
64 finished FDA listings contain Levonorgestrel as their only active ingredient; 5 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVONORGESTREL, LEVONORGESTREL ACETATE, LEVONORGESTREL BUTYRATE
- Dosage forms
- Intrauterine Device, Tablet
- Routes
- Intrauterine, Oral
- Manufacturers / labelers
- 37
- Strengths listed
- 1.5 mg/1 · 1.5 mg/1.5mg · 13.5 mg/1 · 19.5 mg/1 · 52 mg/1
- Brand names in FDA listings
- After Banger, Aftera, Afterpill, Afterplan, Amazon Basic Care Levonorgestrel, Athentia Next, Econ Morning After, Econtra One-Step, Fem Choice Morning After, Her Style, Ithappenz Morning After, Julie, Julie Morning After Pill, Kyleena, Leader Emergency Contraceptive Levonorgestrel, Liletta, Mirena, Morning After, Morning After Pill, My After Plan, My Choice, My Choice Tm, My Way, New Day, Next Choice One Dose, Opcicon One-Step, Option 2, Optionelle, Plan B One-Step, Postday One-Step, Restart, Shewise, Skyla, Take Action
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6373
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021225 | BAYER HLTHCARE | 2000-12-06 | 1 |
| NDA 021998 | FDN CONSUMER | 2009-07-10 | 6 |
| NDA 203159 | BAYER HLTHCARE | 2013-01-09 | 1 |
| ANDA 202508 | NOVEL LABS INC | 2013-02-22 | 2 |
| ANDA 201446 | LUPIN | 2014-06-19 | 4 |
| ANDA 202334 | PERRIGO R AND D | 2014-08-20 | 2 |
| ANDA 202635 | SUN PHARM | 2014-09-11 | 8 |
| NDA 206229 | MEDICINES360 | 2015-02-26 | 1 |
| ANDA 202380 | NAARI PTE | 2015-05-29 | 3 |
| ANDA 206867 | AUROBINDO PHARMA | 2015-12-08 | 15 |
| ANDA 207976 | NOVAST LABS | 2016-03-11 | 2 |
| ANDA 207044 | GLENMARK PHARMS LTD | 2016-03-25 | 4 |
| NDA 208224 | BAYER HLTHCARE | 2016-09-16 | 1 |
| ANDA 205329 | XIROMED | 2018-09-18 | 6 |
| ANDA 207660 | NAARI PTE | 2019-05-02 | 6 |
| ANDA 219102 | ANNORA PHARMA | 2025-09-30 | 2 |
Official labeling on DailyMed
- LEVONORGESTREL TABLET [YYBA CORP] · version 3 · 2026-09-02
- SHEWISE (LEVONORGESTREL) TABLET [GLENMARK THERAPEUTICS INC., USA] · version 5 · 2026-07-16
- LEVONORGESTREL TABLET [GLENMARK THERAPEUTICS INC., USA] · version 2 · 2026-07-16
- RESTART (LEVONORGESTREL) TABLET [WINX HEALTH INC.] · version 7 · 2026-07-06
- OPTION 2 (LEVONORGESTREL) TABLET [L. PERRIGO COMPANY] · version 2 · 2026-06-30
- LEVONORGESTREL TABLET [RUGBY LABORATORIES] · version 4 · 2026-06-12
- LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL (LEVONORGESTREL) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER] · version 5 · 2026-05-11
- MY CHOICE (LEVONORGESTREL) TABLET [OHM LABORATORIES INC] · version 1 · 2026-05-01
- LEVONORGESTREL (LEVONORGESTREL) TABLET [CAMBER CONSUMER CARE INC] · version 2 · 2026-03-26
- SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.] · version 22 · 2026-03-05
- LEVONORGESTREL TABLET [YYBA CORP] · version 2 · 2026-03-02
- HER STYLE (LEVONORGESTREL) TABLET [INGENUS PHARMACEUTICALS, LLC] · version 3 · 2025-12-10
Showing the 12 most recent of 58 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.