Levetiracetam
- Product NDC
- 25021-780
- 11-digit product format
- 250210780
- Labeler code
- 25021
- Product ID
- 25021-780_71dae9d8-f833-46d3-9b2a-c7760742f412
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA091627
- Marketing category
- ANDA
- Marketing start
- 2013-11-01
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/5mL
- 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 | 500 mg/5mL |
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 |
|---|
| 25021-780-05 | Levetiracetam | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 18 |
| 25021-780-05 | Levetiracetam | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Levetiracetam | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
| Levetiracetam | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-780 | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240711_f00d8f59-c333-48ad-aca3-98a49bcd228e.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 |
|---|
| 25021-780-05 | 25021078005 | 10 VIAL in 1 CARTON (25021-780-05) / 5 mL in 1 VIAL | 10 vial | 2013-11-01 | 0000-00-00 | No | No | Current |