Levetiracetam
- Product NDC
- 70518-3804
- 11-digit product format
- 705183804
- Labeler code
- 70518
- Product ID
- 70518-3804_3b296ca7-548a-49c3-e063-6394a90a1849
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA079063
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- 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 | 403884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3804-0 | Levetiracetam | 10 in 1 BOX | SOLUTION | 10 | | 6 |
| 70518-3804-1 | Levetiracetam | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 6 |
| 70518-3804-2 | Levetiracetam | 10 in 1 BOX | SOLUTION | 10 | | 6 |
| 70518-3804-3 | Levetiracetam | 25 mL in 1 CUP, UNIT-DOSE | SOLUTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3804 | LEVETIRACETAM SOLUTION [REMEDYREPACK INC.] | 5 | Current NDC, 4 package rows | 20250429_74ccc9f1-b957-4b1b-9464-1b5e3318c916.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 |
|---|
| 70518-3804-0 | 70518380400 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3804-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-3804-1) | | 2023-07-24 | No | No | Historical |
| 70518-3804-1 | 70518380401 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 70518-3804-2 | 70518380402 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3804-2) / 25 mL in 1 CUP, UNIT-DOSE (70518-3804-3) | | 2023-07-24 | No | No | Historical |
| 70518-3804-3 | 70518380403 | 25 mL in 1 CUP, UNIT-DOSE | 25 ml | | | | Historical |