Lacosamide
- Product NDC
- 82804-991
- 11-digit product format
- 828040991
- Labeler code
- 82804
- Product ID
- 82804-991_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA205237
- Marketing category
- ANDA
- Marketing start
- 2023-07-10
- Substance
- LACOSAMIDE
- Active strength
- 100 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 563KS2PQY5 | LACOSAMIDE | 175481-36-4 | LACOSAMIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-991-00 | 82804099100 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00) | 2024-05-21 | No | No | Historical |
| 82804-991-11 | 82804099111 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11) | 2024-05-21 | No | No | Historical |
| 82804-991-30 | 82804099130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30) | 2024-05-21 | No | No | Historical |
| 82804-991-55 | 82804099155 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55) | 2024-05-21 | No | No | Historical |
| 82804-991-60 | 82804099160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60) | 2024-05-21 | No | No | Historical |
| 82804-991-64 | 82804099164 | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64) | 2024-05-21 | No | No | Historical |
| 82804-991-72 | 82804099172 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72) | 2024-05-21 | No | No | Historical |
| 82804-991-78 | 82804099178 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78) | 2024-05-21 | No | No | Historical |
| 82804-991-90 | 82804099190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90) | 2024-05-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lacosamide | Proficient Rx LP | 2024-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |