Provigil
- Product NDC
- 60505-4852
- 11-digit product format
- 605054852
- Labeler code
- 60505
- Product ID
- 60505-4852_ff96d3ff-6a1c-2545-b939-f383e0262179
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- NDA020717
- Marketing category
- NDA
- Marketing start
- 2025-08-31
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Provigil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MODAFINIL | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R3UK8X3U3D |
| Rxcui | 205324, 213471, 226426, 260218 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-4852-3 | Provigil | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4852-3 | 60505485203 | 30 TABLET in 1 BOTTLE (60505-4852-3) | 30 tablet | 2025-08-31 | No | No | Current |
| 60505-4852-7 | 60505485207 | 16000 TABLET in 1 PAIL (60505-4852-7) | 16000 tablet | 24-APR-25 | | | Current |