Keppra
- Product NDC
- 50474-002
- 11-digit product format
- 504740002
- Labeler code
- 50474
- Product ID
- 50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- UCB, Inc.
- Application
- NDA021872
- Marketing category
- NDA
- Marketing start
- 2006-08-23
- 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
- Keppra
- 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, 647123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50474-002-63 | Keppra | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 29 |
| 50474-002-63 | Keppra | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levetiracetam | ACTIVE INGREDIENT | 44YRR34555 | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
| levetiracetam | ACTIVE MOIETY | 44YRR34555 | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50474-002 | KEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.] | 26 | Current NDC, Legacy NDC, 2 package rows | 20240322_c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e.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 |
|---|
| 50474-002-63 | 50474000263 | 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE | 2006-08-23 | 0000-00-00 | No | No | Current |