Modafinil
- Product NDC
- 0904-6792
- 11-digit product format
- 009046792
- Labeler code
- 0904
- Product ID
- 0904-6792_9b081f9e-c042-4aa8-833a-0701015ab9a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Modafinil
- 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, 260218 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6792-04 | Modafinil | 30 in 1 CARTON | TABLET | 30 | | 4 |
| 0904-6792-04 | Modafinil | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6792 | MODAFINIL TABLET [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250316_4a7ab52b-db31-4774-a06a-b11f2bb60662.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6792-04 | 00904679204 | 30 BLISTER PACK in 1 CARTON (0904-6792-04) / 1 TABLET in 1 BLISTER PACK | 30 blister pack | 2014-02-03 | 0000-00-00 | No | No | Current |