Modafinil
- Product NDC
- 71335-2501
- 11-digit product format
- 713352501
- Labeler code
- 71335
- Product ID
- 71335-2501_08b24ff6-853b-4b93-bdfc-0deb84c837b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207196
- Marketing category
- ANDA
- Marketing start
- 2024-02-21
- 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 |
|---|
| 71335-2501-0 | Modafinil | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
| 71335-2501-1 | Modafinil | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 71335-2501-2 | Modafinil | 18 in 1 BOTTLE, PLASTIC | TABLET | 18 | | 1 |
| 71335-2501-3 | Modafinil | 16 in 1 BOTTLE, PLASTIC | TABLET | 16 | | 1 |
| 71335-2501-4 | Modafinil | 8 in 1 BOTTLE, PLASTIC | TABLET | 8 | | 1 |
| 71335-2501-5 | Modafinil | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 1 |
| 71335-2501-6 | Modafinil | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 71335-2501-7 | Modafinil | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
| 71335-2501-8 | Modafinil | 45 in 1 BOTTLE, PLASTIC | TABLET | 45 | | 1 |
| 71335-2501-9 | Modafinil | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2501 | MODAFINIL TABLET [BRYANT RANCH PREPACK] | 1 | Current NDC, 10 package rows | 20241006_3f733d7f-1213-4534-9433-0eb99a5abc2c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2501-0 | 71335250100 | 100 TABLET in 1 BOTTLE, PLASTIC (71335-2501-0) | 100 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-1 | 71335250101 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-2501-1) | 30 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-2 | 71335250102 | 18 TABLET in 1 BOTTLE, PLASTIC (71335-2501-2) | 18 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-3 | 71335250103 | 16 TABLET in 1 BOTTLE, PLASTIC (71335-2501-3) | 16 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-4 | 71335250104 | 8 TABLET in 1 BOTTLE, PLASTIC (71335-2501-4) | 8 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-5 | 71335250105 | 10 TABLET in 1 BOTTLE, PLASTIC (71335-2501-5) | 10 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-6 | 71335250106 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-2501-6) | 60 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-7 | 71335250107 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-2501-7) | 90 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-8 | 71335250108 | 45 TABLET in 1 BOTTLE, PLASTIC (71335-2501-8) | 45 tablet | 2024-09-23 | No | No | Current |
| 71335-2501-9 | 71335250109 | 180 TABLET in 1 BOTTLE, PLASTIC (71335-2501-9) | 180 tablet | 2024-09-23 | No | No | Current |