Lacosamide
- Product NDC
- 27808-243
- 11-digit product format
- 278080243
- Labeler code
- 27808
- Product ID
- 27808-243_299cd2a3-f5a6-4e6e-8f26-84da23cff30c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Tris Pharma Inc
- Application
- ANDA208308
- Marketing category
- ANDA
- Marketing start
- 2022-03-19
- 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 |
|---|
| 27808-243-01 | Lacosamide | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-243 | LACOSAMIDE TABLET [TRIS PHARMA INC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20230627_7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 27808-243-01 | 27808024301 | 60 TABLET in 1 BOTTLE (27808-243-01) | 60 tablet | 2022-03-19 | 0000-00-00 | No | No | Current |