Lacosamide
- Product NDC
- 10135-802
- 11-digit product format
- 101350802
- Labeler code
- 10135
- Product ID
- 10135-802_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
- 200 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| fac83aa9-21ef-4152-b501-369c0bc4765b | Product name | 1 | 20231010 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| c8c500b5-16db-e0e3-fdf1-c683d7be70e3 | Product name | 3 | 20161117 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-802-60 | Lacosamide | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 2 | |
| 10135-802-86 | Lacosamide | 6 in 1 CARTON | TABLET, FILM COATED | 6 | 2 | |
| 10135-802-86 | Lacosamide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-802-60 | EA - Each | 10135-802 | 9ba06f14-d50d-4c22-8064-50d437981337 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 809987 | lacosamide 100 MG Oral Tablet | PSN | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 809992 | lacosamide 150 MG Oral Tablet | PSN | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 809996 | lacosamide 200 MG Oral Tablet | PSN | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 810000 | lacosamide 50 MG Oral Tablet | PSN | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 809987 | lacosamide 100 MG Oral Tablet | SCD | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 809992 | lacosamide 150 MG Oral Tablet | SCD | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 809996 | lacosamide 200 MG Oral Tablet | SCD | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
| 810000 | lacosamide 50 MG Oral Tablet | SCD | 0a273024-c2d2-4fae-90c3-b2f38a323f24 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 10135-802-60 | 10135080260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-802-60) | 2025-07-01 | No | No | Historical |
| 10135-802-86 | 10135080286 | 6 in 1 CARTON | Historical |