Modafinil
- Product NDC
- 71205-477
- 11-digit product format
- 712050477
- Labeler code
- 71205
- Product ID
- 71205-477_96c761c6-0ba4-4e37-a3e5-4c00762b4a7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202566
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Substance
- MODAFINIL
- Active strength
- 100 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 |
|---|
| 71205-477-30 | 71205047730 | 30 TABLET in 1 BOTTLE (71205-477-30) | 30 tablet | 2020-09-29 | No | No | Historical |
| 71205-477-60 | 71205047760 | 60 TABLET in 1 BOTTLE (71205-477-60) | 60 tablet | 2020-09-29 | No | No | Historical |
| 71205-477-90 | 71205047790 | 90 TABLET in 1 BOTTLE (71205-477-90) | 90 tablet | 2020-09-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Modafinil | Proficient Rx LP | 2023-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |