Modafinil
- Product NDC
- 68788-8653
- 11-digit product format
- 687888653
- Labeler code
- 68788
- Product ID
- 68788-8653_7cd7e2ce-ecdf-4660-93e9-ee86e985d0a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207196
- Marketing category
- ANDA
- Marketing start
- 2024-05-09
- Substance
- MODAFINIL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [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 |
|---|
| R3UK8X3U3D | MODAFINIL | 68693-11-8 | MODAFINIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8653-3 | 68788865303 | 30 TABLET in 1 BOTTLE (68788-8653-3) | 30 tablet | 2024-05-09 | No | No | Historical |
| 68788-8653-6 | 68788865306 | 60 TABLET in 1 BOTTLE (68788-8653-6) | 60 tablet | 2024-05-09 | No | No | Historical |
| 68788-8653-9 | 68788865309 | 90 TABLET in 1 BOTTLE (68788-8653-9) | 90 tablet | 2024-05-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Modafinil | Preferred Pharmaceuticals Inc. | 2025-08-13 | HUMAN PRESCRIPTION DRUG LABEL | 2 |