Levetiracetam
- Product NDC
- 65145-175
- 11-digit product format
- 651450175
- Labeler code
- 65145
- Product ID
- 65145-175_b14657e5-789e-4933-aeb9-78509d79b792
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam in Sodium Chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA219562
- Marketing category
- ANDA
- Marketing start
- 2025-06-24
- Substance
- LEVETIRACETAM
- Active strength
- 1500 mg/100mL
- 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 | 1500 mg/100mL |
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 |
|---|
| 65145-175-01 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | | 2 |
| 65145-175-01 | Levetiracetam | 1 in 1 POUCH | INJECTION | 1 | | 2 |
| 65145-175-10 | Levetiracetam | 10 in 1 CASE | INJECTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-175 | LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE) INJECTION [CAPLIN STERILES LIMITED] | 1 | Current NDC, 3 package rows | 20250131_563171fb-df26-4f95-853a-fd7707da291c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-175-01 | 65145017501 | 100 mL in 1 BAG | 100 ml | | | | Historical |
| 65145-175-10 | 65145017510 | 10 POUCH in 1 CASE (65145-175-10) / 1 BAG in 1 POUCH (65145-175-01) / 100 mL in 1 BAG | 10 pouch | 2025-06-24 | No | No | Historical |