Modafinil
- Product NDC
- 70771-1051
- 11-digit product format
- 707711051
- Labeler code
- 70771
- Product ID
- 70771-1051_e22df34a-3c16-4062-9882-be9840afb8cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA209966
- Marketing category
- ANDA
- Marketing start
- 2018-01-04
- 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 |
|---|
| 70771-1051-1 | Modafinil | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 70771-1051-3 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 70771-1051-9 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1051 | MODAFINIL TABLET [ZYDUS LIFESCIENCES LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240821_f39820fb-8248-4d42-854c-6fe2d9b92d36.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 |
|---|
| 70771-1051-1 | 70771105101 | 100 TABLET in 1 BOTTLE (70771-1051-1) | 100 tablet | 2018-01-04 | 0000-00-00 | No | No | Current |
| 70771-1051-3 | 70771105103 | 30 TABLET in 1 BOTTLE (70771-1051-3) | 30 tablet | 2018-01-04 | 0000-00-00 | No | No | Current |
| 70771-1051-9 | 70771105109 | 90 TABLET in 1 BOTTLE (70771-1051-9) | 90 tablet | 2018-01-04 | 0000-00-00 | No | No | Current |