Levetiracetam
- Product NDC
- 70518-4125
- 11-digit product format
- 705184125
- Labeler code
- 70518
- Product ID
- 70518-4125_3c5503f0-b200-3733-e063-6394a90a0ec9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205130
- Marketing category
- ANDA
- Marketing start
- 2024-07-01
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 44YRR34555 | LEVETIRACETAM | 102767-28-2 | LEVETIRACETAM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4125-0 | 70518412500 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4125-0) | 2024-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Levetiracetam ER | REMEDYREPACK INC. | 2025-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 3 |