LACOSAMIDE
- Product NDC
- 83854-002
- 11-digit product format
- 838540002
- Labeler code
- 83854
- Product ID
- 83854-002_491d8945-109a-8c82-e063-6394a90a7a04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACOSAMIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Anthea Pharma Private Limited
- Application
- ANDA220268
- Marketing category
- ANDA
- Marketing start
- 2026-01-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LACOSAMIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 83854-002-01 | LACOSAMIDE | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 5 |
| 83854-002-10 | LACOSAMIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83854-002-01 | 83854000201 | 20 mL in 1 VIAL | 20 ml | | | | Historical |
| 83854-002-10 | 83854000210 | 10 VIAL in 1 CARTON (83854-002-10) / 20 mL in 1 VIAL (83854-002-01) | 10 vial | 2026-01-21 | No | No | Current |