Modafinil
- Product NDC
- 55253-802
- 11-digit product format
- 552530802
- Labeler code
- 55253
- Product ID
- 55253-802_428b6de2-f791-43db-a186-d19312a348fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CIMA LABS INC.
- Application
- NDA020717
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-03-29
- Marketing end
- 2027-02-28
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Modafinil
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 |
|---|
| 55253-802-30 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 20 |
| 55253-802-90 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55253-802 | MODAFINIL TABLET [CIMA LABS INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240229_9f3b0bd2-72a3-411f-aeec-b533373f1a97.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 |
|---|
| 55253-802-30 | 55253080230 | 30 TABLET in 1 BOTTLE (55253-802-30) | 30 tablet | 2012-03-29 | 2026-06-30 | No | No | Current |
| 55253-802-90 | 55253080290 | 90 TABLET in 1 BOTTLE (55253-802-90) | 90 tablet | 2012-03-29 | 2027-02-28 | No | No | Current |