Active ingredient
Eszopiclone
93 finished FDA listings contain Eszopiclone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ESZOPICLONE
- Dosage forms
- Tablet, Coated, Tablet, Film Coated
- Routes
- Oral, Oropharyngeal
- Manufacturers / labelers
- 28
- Strengths listed
- 1 mg/1 · 2 mg/1 · 3 mg/1
- Brand names in FDA listings
- Lunesta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 461016
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 021476 | WAYLIS THERAP | 2004-12-15 | 3 |
| ANDA 091169 | TEVA | 2011-05-23 | 4 |
| ANDA 091124 | LUPIN LTD | 2011-09-13 | 7 |
| ANDA 091151 | MYLAN PHARMS INC | 2013-03-26 | 6 |
| ANDA 091103 | SUN PHARM | 2013-04-03 | 3 |
| ANDA 091166 | GLENMARK PHARMS LTD | 2014-04-15 | 16 |
| ANDA 091024 | DR REDDYS | 2014-04-15 | 5 |
| ANDA 091113 | ORBION PHARMS | 2014-06-10 | 3 |
| ANDA 202929 | MACLEODS PHARMS | 2015-01-30 | 25 |
| ANDA 208451 | AUROBINDO PHARMA | 2016-09-15 | 16 |
| ANDA 205504 | HETERO LABS LTD V | 2024-01-04 | 5 |
Official labeling on DailyMed
- ESZOPICLONE TABLET, FILM COATED [REMEDYREPACK INC.] · version 2 · 2026-09-11
- ESZOPICLONE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-10
- ESZOPICLONE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-09-02
- ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 102 · 2026-05-25
- ESZOPICLONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-04-21
- ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 9 · 2026-04-16
- ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 9 · 2026-04-16
- ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-04-14
- ESZOPICLONE TABLET, FILM COATED [REMEDYREPACK INC.] · version 5 · 2026-04-14
- ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-04-14
- ESZOPICLONE TABLET, FILM COATED [ASCLEMED USA, INC.] · version 2 · 2026-03-11
- ESZOPICLONE TABLET, FILM COATED [DIRECT RX] · version 5 · 2026-03-06
Showing the 12 most recent of 62 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.