Lacosamide
- Product NDC
- 10135-801
- 11-digit product format
- 101350801
- Labeler code
- 10135
- Product ID
- 10135-801_67afbd17-4406-4e18-a302-c0a5829ec903
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc
- Application
- ANDA218014
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- LACOSAMIDE
- Active strength
- 150 mg/1
- 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 809987, 809992, 809996, 810000 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-801-60 | Lacosamide | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
| 10135-801-86 | Lacosamide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 10135-801-86 | Lacosamide | 6 in 1 CARTON | TABLET, FILM COATED | 6 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-801-60 | 10135080160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-801-60) | 2025-07-01 | No | No | Current |
| 10135-801-86 | 10135080186 | 10 in 1 BLISTER PACK | | | | Historical |