Lacosamide
- Product NDC
- 29300-367
- 11-digit product format
- 293000367
- Labeler code
- 29300
- Product ID
- 29300-367_d452fee5-4940-4740-8c4d-8024788eafc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA213109
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- Substance
- LACOSAMIDE
- Active strength
- 200 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 | 200 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 |
|---|
| 29300-367-05 | Lacosamide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 29300-367-16 | Lacosamide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-367 | LACOSAMIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 6 | Current NDC, 2 package rows | 20241202_7ed5cebe-470e-48a4-86ec-2ce79cc32688.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 29300-367-05 | 29300036705 | 500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05) | 2024-12-01 | No | No | Historical |
| 29300-367-16 | 29300036716 | 60 TABLET, FILM COATED in 1 BOTTLE (29300-367-16) | 2024-12-01 | No | No | Historical |