LEVETIRACETAM solution
- Product NDC
- 62135-548
- 11-digit product format
- 621350548
- Labeler code
- 62135
- Product ID
- 62135-548_4ce97296-8459-d216-e063-6394a90a1f42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA090263
- Marketing category
- ANDA
- Marketing start
- 2009-04-03
- Substance
- LEVETIRACETAM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVETIRACETAM solution
- Listing expiration
- 2027-12-31
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 |
|---|
| 62135-548-47 | LEVETIRACETAM solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-548 | LEVETIRACETAM SOLUTION (LEVETIRACETAM) SOLUTION [CHARTWELL RX, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240601_61eb57a9-5df2-4426-9f0c-a75e2f356b11.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 |
|---|
| 62135-548-47 | 62135054847 | 473 mL in 1 BOTTLE (62135-548-47) | 473 ml | 2022-06-08 | 0000-00-00 | No | No | Current |