Lacosamide
- Product NDC
- 69367-348
- 11-digit product format
- 693670348
- Labeler code
- 69367
- Product ID
- 69367-348_600757f7-b2e8-4c8e-aaf6-c468d7ada9a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lacosamide
- Listing expiration
- 2027-12-31
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 |
|---|
| 69367-348-60 | Lacosamide | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-348 | LACOSAMIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20230718_ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-348-60 | 69367034860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-348-60) | 2023-07-10 | No | No | Current |