Lacosamide
- Product NDC
- 65862-747
- 11-digit product format
- 658620747
- Labeler code
- 65862
- Product ID
- 65862-747_94178e21-7985-474b-9676-b84410e58a97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA204994
- Marketing category
- ANDA
- Marketing start
- 2023-01-05
- 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 |
|---|
| 65862-747-03 | Lacosamide | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 6 |
| 65862-747-10 | Lacosamide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 65862-747-60 | 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 |
|---|
| 65862-747 | LACOSAMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, 3 package rows | 20241019_6140b3f1-ff60-427c-91d7-15af99fd78f1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65862-747-03 | 65862074703 | 3 BLISTER PACK in 1 CARTON (65862-747-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-747-10) | 3 blister pack | 2023-01-05 | No | No | Current |
| 65862-747-10 | 65862074710 | 10 in 1 BLISTER PACK | | | | | Historical |
| 65862-747-60 | 65862074760 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-747-60) | | 2023-01-05 | No | No | Current |