modafinil
- Product NDC
- 43353-925
- 11-digit product format
- 433530925
- Labeler code
- 43353
- Product ID
- 43353-925_01f751d9-8907-4a54-b2e9-f57a8f150920
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA020717
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-03-29
- 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 |
|---|
| 43353-925-30 | modafinil | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 43353-925-53 | modafinil | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-925 | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20171220_cad4201c-133c-4a61-9d93-3c5e51695430.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 |
|---|
| 43353-925-30 | 43353092530 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30) | 30 tablet | 2014-04-17 | 0000-00-00 | No | No | Current |
| 43353-925-53 | 43353092553 | 60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53) | 60 tablet | 2014-04-17 | 0000-00-00 | No | No | Current |