Levetiracetam
- Product NDC
- 48433-052
- 11-digit product format
- 484330052
- Labeler code
- 48433
- Product ID
- 48433-052_4f0c308f-3ef4-05f9-e063-6394a90ab87b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA076919
- Marketing category
- ANDA
- Marketing start
- 2026-03-18
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-052-01 | Levetiracetam | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
| 48433-052-20 | Levetiracetam | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-052-01 | 48433005201 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-052-20 | 48433005220 | 100 BLISTER PACK in 1 CARTON (48433-052-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-052-01) | 100 blister pack | 2026-03-18 | No | No | Historical |