LACOSAMIDE
- Product NDC
- 50228-193
- 11-digit product format
- 502280193
- Labeler code
- 50228
- Product ID
- 50228-193_56788345-3f8e-478c-b73d-216b4d711b57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACOSAMIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA205237
- Marketing category
- ANDA
- Marketing start
- 2022-03-18
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LACOSAMIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACOSAMIDE | 100 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 |
|---|
| 50228-193-10 | LACOSAMIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 50228-193-30 | LACOSAMIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 50228-193-60 | LACOSAMIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-193 | LACOSAMIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240616_f4ffa3ad-1278-4772-9ef8-ed6fdaa47605.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-193-10 | 50228019310 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-193-10) | 2022-03-18 | 0000-00-00 | No | No | Current |
| 50228-193-30 | 50228019330 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-193-30) | 2022-03-18 | 0000-00-00 | No | No | Current |
| 50228-193-60 | 50228019360 | 60 TABLET, FILM COATED in 1 BOTTLE (50228-193-60) | 2022-03-18 | 0000-00-00 | No | No | Current |