Levetiracetam
- Product NDC
- 53041-660
- 11-digit product format
- 530410660
- Labeler code
- 53041
- Product ID
- 53041-660_afb5dc0d-459c-441a-bc79-d6a9b5428e10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- ANDA218080
- Marketing category
- ANDA
- Marketing start
- 2025-12-02
- Substance
- LEVETIRACETAM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 403884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-660-06 | Levetiracetam | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53041-660-06 | 53041066006 | 473 mL in 1 BOTTLE (53041-660-06) | 473 ml | 2025-12-02 | No | No | Current |