Modafinil
- Product NDC
- 71610-685
- 11-digit product format
- 716100685
- Labeler code
- 71610
- Product ID
- 71610-685_e12198af-3556-407d-bac7-29b6ea6cc45f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077667
- Marketing category
- ANDA
- Marketing start
- 2014-02-03
- 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 |
|---|
| 71610-685-30 | 71610068530 | 30 TABLET in 1 BOTTLE (71610-685-30) | 30 tablet | 2023-01-11 | No | No | Historical |
| 71610-685-53 | 71610068553 | 60 TABLET in 1 BOTTLE (71610-685-53) | 60 tablet | 2023-01-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Modafinil | Aphena Pharma Solutions - Tennessee, LLC | 2023-01-16 | HUMAN PRESCRIPTION DRUG LABEL | 2 |