Armodafinil
- Product NDC
- 0378-3433
- 11-digit product format
- 003783433
- Labeler code
- 0378
- Product ID
- 0378-3433_34fcca9f-37ba-40d9-9032-6ffeeb031a36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200043
- Marketing category
- ANDA
- Marketing start
- 2016-06-01
- Substance
- ARMODAFINIL
- Active strength
- 250 mg/1
- 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
- Armodafinil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARMODAFINIL | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V63XWA605I |
| Rxcui | 724859, 724861, 724863 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-3433-93 | Armodafinil | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-3433 | ARMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240712_de0799f7-7644-4057-a7da-75436f978c61.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 |
|---|
| 0378-3433-93 | 00378343393 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-3433-93) | 30 tablet | 2016-06-01 | 0000-00-00 | No | No | Current |