Modafinil
- Product NDC
- 0378-5573
- 11-digit product format
- 003785573
- Labeler code
- 0378
- Product ID
- 0378-5573_f6947bbc-082d-48f6-ab5e-06610359865d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076594
- Marketing category
- ANDA
- Marketing start
- 2012-08-10
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5573-05 | 00378557305 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-5573-05) | 500 tablet | 2012-08-10 | 0000-00-00 | No | No | Current |
| 0378-5573-93 | 00378557393 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-5573-93) | 30 tablet | 2012-08-10 | 0000-00-00 | No | No | Current |