Levetiracetam
- Product NDC
- 82009-124
- 11-digit product format
- 820090124
- Labeler code
- 82009
- Product ID
- 82009-124_4090ba40-7f20-ea57-e063-6294a90acaa8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA090515
- Marketing category
- ANDA
- Marketing start
- 2023-07-19
- 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 |
|---|
| 82009-124-60 | Levetiracetam | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-124 | LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, 1 package rows | 20240802_3756f052-919c-4817-a56e-1091fd514d9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-124-60 | 82009012460 | 60 TABLET, FILM COATED in 1 BOTTLE (82009-124-60) | 2023-07-19 | No | No | Current |