Levetiracetam
- Product NDC
- 43547-880
- 11-digit product format
- 435470880
- Labeler code
- 43547
- Product ID
- 43547-880_57f09129-7151-4a75-9d73-9dd32f74ba43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA078106
- Marketing category
- ANDA
- Marketing start
- 2024-09-01
- Substance
- LEVETIRACETAM
- Active strength
- 250 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311288, 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-880-15 | Levetiracetam | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 43547-880-50 | Levetiracetam | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-880 | LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | Current NDC, 2 package rows | 20250406_57f09129-7151-4a75-9d73-9dd32f74ba43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43547-880-15 | 43547088015 | 120 TABLET, FILM COATED in 1 BOTTLE (43547-880-15) | 2024-09-01 | No | No | Historical |
| 43547-880-50 | 43547088050 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-880-50) | 2024-09-01 | No | No | Historical |