LEVETIRACETAM
- Product NDC
- 42571-331
- 11-digit product format
- 425710331
- Labeler code
- 42571
- Product ID
- 42571-331_1ccd66c0-e671-efb8-e063-6394a90aed04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Micro Labs Limited
- Application
- ANDA211954
- Marketing category
- ANDA
- Marketing start
- 2019-10-04
- 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 |
|---|
| 42571-331-92 | LEVETIRACETAM | 5 mL in 1 VIAL | INJECTION | 5 | | 8 |
| 42571-331-92 | LEVETIRACETAM | 10 in 1 CARTON | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-331 | LEVETIRACETAM (LEVETIRACETAM) INJECTION [MICRO LABS LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240710_1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4.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 |
|---|
| 42571-331-92 | 42571033192 | 10 VIAL in 1 CARTON (42571-331-92) / 5 mL in 1 VIAL | 10 vial | 2019-10-04 | 0000-00-00 | No | No | Current |