Modafinil
- Product NDC
- 82804-126
- 11-digit product format
- 828040126
- Labeler code
- 82804
- Product ID
- 82804-126_c332ea93-48d9-4c8a-a1ef-01c27a61350b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209966
- Marketing category
- ANDA
- Marketing start
- 2019-02-15
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-126-30 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-126 | MODAFINIL TABLET [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20240724_c332ea93-48d9-4c8a-a1ef-01c27a61350b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-126-30 | 82804012630 | 30 TABLET in 1 BOTTLE (82804-126-30) | 30 tablet | 2024-07-17 | No | No | Historical |