Lacosamide
- Product NDC
- 60505-6235
- 11-digit product format
- 605056235
- Labeler code
- 60505
- Product ID
- 60505-6235_ac0cc20b-2d3d-443f-c447-71aef269849e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lacosamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp
- Application
- ANDA216670
- Marketing category
- ANDA
- Marketing start
- 2024-02-20
- 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 |
|---|
| 60505-6235-4 | Lacosamide | 10 in 1 CARTON | INJECTION | 10 | | 3 |
| 60505-6235-4 | Lacosamide | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6235 | LACOSAMIDE INJECTION [APOTEX CORP] | 2 | Current NDC, 2 package rows | 20240323_2c53d6c3-fe18-dce6-a710-cb874fbf0c59.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-6235-4 | 60505623504 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6235-4) / 20 mL in 1 VIAL, SINGLE-DOSE | 2024-02-20 | No | No | Historical |