Lacosamide
- Product NDC
- 69367-352
- 11-digit product format
- 693670352
- Labeler code
- 69367
- Product ID
- 69367-352_89a391c2-4a46-47bc-976a-989442b47c56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA218706
- Marketing category
- ANDA
- Marketing start
- 2025-05-23
- 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
- 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 | 809974 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-352-10 | Lacosamide | 10 in 1 CARTON | INJECTION | 10 | | 1 |
| 69367-352-20 | Lacosamide | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-352-10 | 69367035210 | 10 VIAL, GLASS in 1 CARTON (69367-352-10) / 20 mL in 1 VIAL, GLASS (69367-352-20) | | 2025-05-23 | No | No | Historical |
| 69367-352-20 | 69367035220 | 20 mL in 1 VIAL, GLASS | 20 ml | | | | Historical |