Levetiracetam
- Product NDC
- 51224-013
- 11-digit product format
- 512240013
- Labeler code
- 51224
- Product ID
- 51224-013_42cf4e4e-931e-8c30-e063-6394a90a9cb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- TAGI Pharma, Inc.
- Application
- ANDA209781
- Marketing category
- ANDA
- Marketing start
- 2018-11-30
- 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 |
|---|
| 51224-013-10 | Levetiracetam | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 5 |
| 51224-013-10 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 5 |
| 51224-013-25 | Levetiracetam | 25 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 25 | | 5 |
| 51224-013-25 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51224-013 | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [TAGI PHARMA, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20211218_72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51224-013-10 | 51224001310 | 10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE | 2018-11-30 | 2026-08-10 | No | No | Current |
| 51224-013-25 | 51224001325 | 25 VIAL, SINGLE-USE in 1 CARTON (51224-013-25) / 5 mL in 1 VIAL, SINGLE-USE | 2018-11-30 | 2026-08-11 | No | No | Current |