Lacosamide
- Product NDC
- 82804-990
- 11-digit product format
- 828040990
- Labeler code
- 82804
- Product ID
- 82804-990_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
- 50 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 | 50 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 |
|---|
| 82804-990-00 | Lacosamide | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
| 82804-990-11 | Lacosamide | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 1 |
| 82804-990-30 | Lacosamide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 82804-990-55 | Lacosamide | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 1 |
| 82804-990-60 | Lacosamide | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 82804-990-64 | Lacosamide | 240 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 240 | | 1 |
| 82804-990-72 | Lacosamide | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 1 |
| 82804-990-78 | Lacosamide | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 1 |
| 82804-990-90 | Lacosamide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-990 | LACOSAMIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 9 package rows | 20240523_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-990-00 | 82804099000 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-00) | 2024-05-21 | No | No | Current |
| 82804-990-11 | 82804099011 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-11) | 2024-05-21 | No | No | Current |
| 82804-990-30 | 82804099030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-30) | 2024-05-21 | No | No | Current |
| 82804-990-55 | 82804099055 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-55) | 2024-05-21 | No | No | Current |
| 82804-990-60 | 82804099060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-60) | 2024-05-21 | No | No | Current |
| 82804-990-64 | 82804099064 | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-64) | 2024-05-21 | No | No | Current |
| 82804-990-72 | 82804099072 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-72) | 2024-05-21 | No | No | Current |
| 82804-990-78 | 82804099078 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-78) | 2024-05-21 | No | No | Current |
| 82804-990-90 | 82804099090 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-990-90) | 2024-05-21 | No | No | Current |