Zaleplon
- Product NDC
- 68788-8725
- 11-digit product format
- 687888725
- Labeler code
- 68788
- Product ID
- 68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090374
- Marketing category
- ANDA
- Marketing start
- 2024-08-16
- Substance
- ZALEPLON
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| S62U433RMH | ZALEPLON | 151319-34-5 | ZALEPLON |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8725-1 | 68788872501 | 100 CAPSULE in 1 BOTTLE (68788-8725-1) | 100 capsule | 2024-08-16 | No | No | Historical |
| 68788-8725-2 | 68788872502 | 20 CAPSULE in 1 BOTTLE (68788-8725-2) | 20 capsule | 2024-08-16 | No | No | Historical |
| 68788-8725-3 | 68788872503 | 30 CAPSULE in 1 BOTTLE (68788-8725-3) | 30 capsule | 2024-08-16 | No | No | Historical |
| 68788-8725-6 | 68788872506 | 60 CAPSULE in 1 BOTTLE (68788-8725-6) | 60 capsule | 2024-08-16 | No | No | Historical |
| 68788-8725-9 | 68788872509 | 90 CAPSULE in 1 BOTTLE (68788-8725-9) | 90 capsule | 2024-08-16 | No | No | Historical |