Levetiracetam
- Product NDC
- 63323-400
- 11-digit product format
- 633230400
- Labeler code
- 63323
- Product ID
- 63323-400_799d949b-b1db-4e10-ab5c-89bf7c1bd308
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA090876
- Marketing category
- ANDA
- Marketing start
- 2015-08-13
- 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 |
|---|
| 63323-400-41 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 7 |
| 63323-400-44 | Levetiracetam | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 7 |
| 63323-400-01 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 6 |
| 63323-400-05 | Levetiracetam | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-400 | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20220323_cc4a06f1-6509-4650-b20c-259a39353733.zip |
| 63323-400 | LEVETIRACETAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220222_cc41696c-9cf0-4410-bacc-09132ee805ce.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 |
|---|
| 63323-400-01 | 63323040001 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |
| 63323-400-05 | 63323040005 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01) | | 2015-08-13 | 0000-00-00 | No | No | Current |
| 63323-400-41 | 63323040041 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |
| 63323-400-44 | 63323040044 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41) | | 2015-08-13 | 0000-00-00 | No | No | Current |