Lacosamide
- Product NDC
- 68083-480
- 11-digit product format
- 680830480
- Labeler code
- 68083
- Product ID
- 68083-480_784837da-eb6c-43e1-87ea-367e2d07cd1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215628
- Marketing category
- ANDA
- Marketing start
- 2022-09-19
- 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 |
|---|
| 68083-480-10 | Lacosamide | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 10 |
| 68083-480-10 | Lacosamide | 10 in 1 CARTON | INJECTION | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-480 | LACOSAMIDE INJECTION [GLAND PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241208_779d2381-f590-45f9-a191-f44af821f4c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-480-10 | 68083048010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 20 mL in 1 VIAL, SINGLE-DOSE | 2022-09-19 | 0000-00-00 | No | No | Current |