Modafinil
- Product NDC
- 0591-3500
- 11-digit product format
- 005913500
- Labeler code
- 0591
- Product ID
- 0591-3500_e008554f-9b68-4afd-a091-9087d298497d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076715
- Marketing category
- ANDA
- Marketing start
- 2013-04-03
- Marketing end
- 2021-11-30
- 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
- 0000-00-00
- 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 |
|---|
| 0591-3500-01 | 00591350001 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-3500-01) | 100 tablet | 2013-04-03 | 2021-11-30 | No | No | Current |
| 0591-3500-30 | 00591350030 | 30 TABLET in 1 BOTTLE, PLASTIC (0591-3500-30) | 30 tablet | 2013-04-03 | 2021-11-30 | No | No | Current |