Lacosamide Oral Solution
- Product NDC
- 67877-732
- 11-digit product format
- 678770732
- Labeler code
- 67877
- Product ID
- 67877-732_c4d07291-0152-4092-a339-3edee132ef09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide Oral Solution
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA214672
- Marketing category
- ANDA
- Marketing start
- 2022-05-20
- Substance
- LACOSAMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lacosamide Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACOSAMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 993856 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-732-95 | Lacosamide Oral Solution | 200 mL in 1 BOTTLE | SOLUTION | 200 | | 20 |
| 67877-732-97 | Lacosamide Oral Solution | 465 mL in 1 BOTTLE | SOLUTION | 465 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-732 | LACOSAMIDE ORAL SOLUTION SOLUTION [ASCEND LABORATORIES, LLC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240831_4ae87834-05d8-43c8-aaa3-78047d4a573c.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 |
|---|
| 67877-732-95 | 67877073295 | 200 mL in 1 BOTTLE (67877-732-95) | 200 ml | 2022-05-20 | 0000-00-00 | No | No | Current |
| 67877-732-97 | 67877073297 | 465 mL in 1 BOTTLE (67877-732-97) | 465 ml | 2022-05-20 | 0000-00-00 | No | No | Current |