Levetiracetam
- Product NDC
- 68083-152
- 11-digit product format
- 680830152
- Labeler code
- 68083
- Product ID
- 68083-152_446e0964-1e66-48ae-8065-da9c88662828
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA206880
- Marketing category
- ANDA
- Marketing start
- 2017-11-07
- Substance
- LEVETIRACETAM
- Active strength
- 5 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 1193358, 1193360, 1193362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-152-01 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | | 12 |
| 68083-152-10 | Levetiracetam | 10 in 1 CARTON | INJECTION | 10 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-152 | LEVETIRACETAM INJECTION [GLAND PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240418_aa883d9c-c6cd-44ab-a1de-058985e4f97f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-152-01 | 68083015201 | 100 mL in 1 BAG | 100 ml | | | | | Historical |
| 68083-152-10 | 68083015210 | 10 BAG in 1 CARTON (68083-152-10) / 100 mL in 1 BAG (68083-152-01) | 10 bag | 2017-11-07 | 0000-00-00 | No | No | Current |