Modafinil
- Product NDC
- 23155-862
- 11-digit product format
- 231550862
- Labeler code
- 23155
- Product ID
- 23155-862_d8fc4961-6cbc-44fc-be5f-63127fff98f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R3UK8X3U3D | MODAFINIL | 68693-11-8 | MODAFINIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-862-01 | 23155086201 | 100 TABLET in 1 BOTTLE (23155-862-01) | 100 tablet | 2024-02-21 | No | No | Historical |
| 23155-862-03 | 23155086203 | 30 TABLET in 1 BOTTLE (23155-862-03) | 30 tablet | 2024-02-21 | No | No | Historical |
| 23155-862-05 | 23155086205 | 500 TABLET in 1 BOTTLE (23155-862-05) | 500 tablet | 2024-02-21 | No | No | Historical |
| 23155-862-09 | 23155086209 | 90 TABLET in 1 BOTTLE (23155-862-09) | 90 tablet | 2024-02-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Modafinil | Preferred Pharmaceuticals Inc. | 2025-08-13 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| Modafinil | Bryant Ranch Prepack | 2024-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Modafinil | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Appco Pharma LLC | VIVIMED LIFE SCIENCES PRIVATE LIMITED | Sidmak Laboratories (India) Pvt. Ltd. | 2024-02-20 | Human Prescription Drug Label | 13 |