Levetiracetam
- Product NDC
- 0378-5613
- 11-digit product format
- 003785613
- Labeler code
- 0378
- Product ID
- 0378-5613_5c6f87fe-aabf-4349-9f1b-a280256dce5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076919
- Marketing category
- ANDA
- Marketing start
- 2008-11-04
- Marketing end
- 2023-03-31
- Substance
- LEVETIRACETAM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5613-05 | 00378561305 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5613-05) | 2008-11-04 | 2023-03-31 | No | No | Current |
| 0378-5613-78 | 00378561378 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5613-78) | 2008-11-04 | 2023-03-31 | No | No | Current |