Lacosamide
- Product NDC
- 0904-7464
- 11-digit product format
- 009047464
- Labeler code
- 0904
- Product ID
- 0904-7464_6e6658af-c86d-4c22-8bd1-3c36e7cece85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA216151
- Marketing category
- ANDA
- Marketing start
- 2024-06-26
- Substance
- LACOSAMIDE
- Active strength
- 100 mg/10mL
- 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 | 100 mg/10mL |
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 |
|---|
| 0904-7464-64 | Lacosamide | 1 in 1 CASE | SOLUTION | 1 | | 16 |
| 0904-7464-64 | Lacosamide | 10 in 1 TRAY | SOLUTION | 10 | | 16 |
| 0904-7464-66 | Lacosamide | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7464 | LACOSAMIDE SOLUTION [MAJOR PHARMACEUTICALS] | 14 | Current NDC, 3 package rows | 20250130_973cea8d-e516-4014-a116-c5990554a550.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7464-64 | 00904746464 | 1 TRAY in 1 CASE (0904-7464-64) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7464-66) | 1 tray | 2024-06-26 | No | No | Current |
| 0904-7464-66 | 00904746466 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |