Active ingredient
Zaleplon
20 finished FDA listings contain Zaleplon as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ZALEPLON
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 10 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 74667
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 |
|---|---|---|---|
| ANDA 078989 | UNICHEM | 2008-06-06 | 7 |
| ANDA 078829 | AUROBINDO PHARMA | 2008-06-06 | 6 |
| ANDA 077237 | HIKMA | 2008-06-06 | 3 |
| ANDA 090374 | ORBION PHARMS | 2009-09-17 | 4 |
Official labeling on DailyMed
- ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 17 · 2025-11-17
- ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 15 · 2025-11-17
- ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2025-11-17
- ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 8 · 2025-11-17
- ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 2 · 2025-11-17
- ZALEPLON CAPSULE [HIKMA PHARMACEUTICALS USA INC.] · version 11 · 2025-03-31
- ZALEPLON CAPSULE [BRYANT RANCH PREPACK] · version 2 · 2024-08-19
- ZALEPLON CAPSULE [BRYANT RANCH PREPACK] · version 3 · 2024-06-03
- ZALEPLON CAPSULE [RISING PHARMA HOLDINGS, INC.] · version 6 · 2024-05-15
- ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] · version 11 · 2024-05-10
- ZALEPLON CAPSULE [BIONPHARMA INC.] · version 1 · 2024-02-19
- ZALEPLON CAPSULE [A-S MEDICATION SOLUTIONS] · version 11 · 2024-01-08
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.