LEVETIRACETAM
- Product NDC
- 0409-2011
- 11-digit product format
- 004092011
- Labeler code
- 0409
- Product ID
- 0409-2011_6af360ce-78a8-4755-973f-1c7ca35648db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA202869
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- 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 | 647121 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-2011-05 | LEVETIRACETAM | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 6 |
| 0409-2011-25 | LEVETIRACETAM | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2011 | LEVETIRACETAM INJECTION, SOLUTION [HOSPIRA, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240606_f1935bc8-30ce-4b51-8a4c-0f12ce9000a6.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 |
|---|
| 0409-2011-05 | 00409201105 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 0409-2011-25 | 00409201125 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-2011-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2011-05) | | 2021-11-01 | 0000-00-00 | No | No | Current |