Lacosamide Oral Solution
- Product NDC
- 82983-427
- 11-digit product format
- 829830427
- Labeler code
- 82983
- Product ID
- 82983-427_9fd5f392-f470-4f19-96da-582fae4da496
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Ajenat Pharmaceuticals LLC
- Application
- ANDA219699
- Marketing category
- ANDA
- Marketing start
- 2025-07-14
- 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 |
|---|
| 82983-427-31 | Lacosamide Oral Solution | 200 mL in 1 BOTTLE, PLASTIC | SOLUTION | 200 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82983-427-31 | 82983042731 | 200 mL in 1 BOTTLE, PLASTIC (82983-427-31) | 200 ml | 2025-07-14 | No | No | Historical |