Levetiracetam
- Product NDC
- 0143-9574
- 11-digit product format
- 001439574
- Labeler code
- 0143
- Product ID
- 0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090981
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- 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 |
|---|
| 0143-9574-01 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 | | 12 |
| 0143-9574-10 | Levetiracetam | 10 in 1 CARTON | INJECTION | 10 | | 12 |
| 0143-9574-25 | Levetiracetam | 25 in 1 CARTON | INJECTION | 25 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9574 | LEVETIRACETAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240920_097e5606-dd5e-4518-ab97-f71f68786444.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 |
|---|
| 0143-9574-01 | 00143957401 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 0143-9574-10 | 00143957410 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01) | | 2015-06-01 | 0000-00-00 | No | No | Current |
| 0143-9574-25 | 00143957425 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01) | | 2015-06-01 | 0000-00-00 | No | No | Current |