Levetiracetam
- Product NDC
- 85957-037
- 11-digit product format
- 859570037
- Labeler code
- 85957
- Product ID
- 85957-037_4f91fcd5-7a0c-9619-e063-6294a90ab937
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Aryeh Pharma corp
- Application
- ANDA091485
- Marketing category
- ANDA
- Marketing start
- 2026-04-10
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/5mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2027-12-31
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 |
|---|
| 85957-037-01 | Levetiracetam | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 2 |
| 85957-037-02 | Levetiracetam | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85957-037-01 | 85957003701 | 5 mL in 1 VIAL | 5 ml | | | | Historical |
| 85957-037-02 | 85957003702 | 10 VIAL in 1 CARTON (85957-037-02) / 5 mL in 1 VIAL (85957-037-01) | 10 vial | 2026-04-10 | No | No | Historical |