Lacosamide
- Product NDC
- 0121-2024
- 11-digit product format
- 001212024
- Labeler code
- 0121
- Product ID
- 0121-2024_80024eb8-f6ab-420a-94df-dc5dd9ffb9b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA216151
- Marketing category
- ANDA
- Marketing start
- 2022-08-26
- Substance
- LACOSAMIDE
- Active strength
- 100 mg/10mL
- 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/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 993856 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-2024-10 | Lacosamide | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 22 |
| 0121-2024-95 | Lacosamide | 1 in 1 TRAY | SOLUTION | 1 | | 22 |
| 0121-2024-95 | Lacosamide | 10 in 1 TRAY | SOLUTION | 10 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-2024 | LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 22 | Current NDC, 3 package rows | 20240601_75de00d8-d2e7-4025-be4e-f49299068e7e.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 |
|---|
| 0121-2024-10 | 00121202410 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 0121-2024-95 | 00121202495 | 1 TRAY in 1 TRAY (0121-2024-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-2024-10) | 1 tray | 2023-04-28 | No | No | Historical |