lacosamide
- Product NDC
- 68462-679
- 11-digit product format
- 684620679
- Labeler code
- 68462
- Product ID
- 68462-679_a496c733-ce38-4566-83f9-0287506f4506
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc. USA
- Application
- ANDA205006
- 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 |
|---|
| 68462-679-10 | lacosamide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
| 68462-679-30 | lacosamide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 68462-679-60 | 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 |
|---|
| 68462-679 | LACOSAMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC. USA] | 4 | Current NDC, Legacy NDC, 3 package rows | 20231115_df1d2e6a-6129-49c9-b2c1-0fdf73f38b9c.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 |
|---|
| 68462-679-10 | 68462067910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-679-10) | 2022-03-18 | 0000-00-00 | No | No | Current |
| 68462-679-30 | 68462067930 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-679-30) | 2022-03-18 | 0000-00-00 | No | No | Current |
| 68462-679-60 | 68462067960 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-679-60) | 2022-03-18 | 0000-00-00 | No | No | Current |