Levetiracetam
- Product NDC
- 50405-303
- 11-digit product format
- 504050303
- Labeler code
- 50405
- Product ID
- 50405-303_8d5b3de5-1dce-43e9-9858-c0439034f86a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SOHM, Inc.
- Application
- ANDA079042
- Marketing category
- ANDA
- Marketing start
- 2024-05-27
- Substance
- LEVETIRACETAM
- Active strength
- 1000 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 | 1000 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 |
|---|
| 50405-303-01 | Levetiracetam | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 50405-303-02 | Levetiracetam | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 50405-303-03 | Levetiracetam | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50405-303-01 | 50405030301 | 30 TABLET in 1 BOTTLE (50405-303-01) | 30 tablet | 2024-05-27 | No | No | Current |
| 50405-303-02 | 50405030302 | 60 TABLET in 1 BOTTLE (50405-303-02) | 60 tablet | 2024-05-27 | No | No | Current |
| 50405-303-03 | 50405030303 | 500 TABLET in 1 BOTTLE (50405-303-03) | 500 tablet | 2024-05-27 | No | No | Current |