Modafinil
- Product NDC
- 65862-601
- 11-digit product format
- 658620601
- Labeler code
- 65862
- Product ID
- 65862-601_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202566
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Substance
- MODAFINIL
- Active strength
- 100 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 | 100 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 |
|---|
| 65862-601-01 | Modafinil | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 65862-601-30 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 65862-601-90 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 11 |
| 65862-601-99 | Modafinil | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-601 | MODAFINIL TABLET [AUROBINDO PHARMA LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240529_f51ca007-3955-4540-a88a-0ddae8d8e8ab.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 |
|---|
| 65862-601-01 | 65862060101 | 100 TABLET in 1 BOTTLE (65862-601-01) | 100 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |
| 65862-601-30 | 65862060130 | 30 TABLET in 1 BOTTLE (65862-601-30) | 30 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |
| 65862-601-81 | 65862060181 | 8000 TABLET in 1 BAG (65862-601-81) | 8000 tablet | 27-SEP-12 | | | | Current |
| 65862-601-90 | 65862060190 | 90 TABLET in 1 BOTTLE (65862-601-90) | 90 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |
| 65862-601-92 | 65862060192 | 90000 TABLET in 1 BAG (65862-601-92) | 90000 tablet | 22-NOV-19 | | | | Current |
| 65862-601-99 | 65862060199 | 1000 TABLET in 1 BOTTLE (65862-601-99) | 1000 tablet | 2012-09-27 | 0000-00-00 | No | No | Current |