Lacosamide
- Product NDC
- 83090-012
- 11-digit product format
- 830900012
- Labeler code
- 83090
- Product ID
- 83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lacosamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sintetica US LLC
- Application
- ANDA217311
- Marketing category
- ANDA
- Marketing start
- 2024-03-15
- 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 |
|---|
| 83090-012-10 | Lacosamide | 10 in 1 CARTON | INJECTION | 10 | | 2 |
| 83090-012-10 | Lacosamide | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83090-012 | LACOSAMIDE INJECTION [SINTETICA US LLC] | 1 | Current NDC, 2 package rows | 20240508_08ac486a-4f61-4e9e-9683-d1a66a6c2a4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83090-012-10 | 83090001210 | 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS | 2024-03-15 | No | No | Current |