Levetiracetam
- Product NDC
- 43598-635
- 11-digit product format
- 435980635
- Labeler code
- 43598
- Product ID
- 43598-635_f5cfc6e1-79f3-bd25-5f66-9ea05bc47def
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam Injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Dr.Reddy's Laboratories Inc
- Application
- ANDA206880
- Marketing category
- ANDA
- Marketing start
- 2018-06-08
- Substance
- LEVETIRACETAM
- Active strength
- 5 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 1193358, 1193360, 1193362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-635-10 | Levetiracetam | 10 in 1 CARTON | INJECTION | 10 | | 4 |
| 43598-635-52 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-635 | LEVETIRACETAM (LEVETIRACETAM INJECTION) INJECTION [DR.REDDY'S LABORATORIES INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220717_0a9234b7-46b1-8e6c-a992-90f86cfb6e00.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 |
|---|
| 43598-635-10 | 43598063510 | 10 BAG in 1 CARTON (43598-635-10) / 100 mL in 1 BAG (43598-635-52) | 10 bag | 2018-06-08 | 0000-00-00 | No | No | Current |
| 43598-635-52 | 43598063552 | 100 mL in 1 BAG | 100 ml | | | | | Historical |