Lacosamide
- Product NDC
- 0121-3968
- 11-digit product format
- 001213968
- Labeler code
- 0121
- Product ID
- 0121-3968_a95d174d-efee-4ba5-8734-9adaad16be27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI
- Application
- ANDA209301
- Marketing category
- ANDA
- Marketing start
- 2022-05-31
- Marketing end
- 0000-00-00
- Substance
- LACOSAMIDE
- Active strength
- 200 mg/20mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-3968-74 | Lacosamide | 20 mL in 1 CUP, UNIT-DOSE | SOLUTION | 20 | | 22 |
| 0121-3968-95 | Lacosamide | 1 in 1 CASE | SOLUTION | 1 | | 22 |
| 0121-3968-95 | 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 |
|---|
| 0121-3968 | LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 22 | Legacy 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-3968-74 | 00121396874 | 20 mL in 1 CUP, UNIT-DOSE | 20 ml | | | | | Historical |
| 0121-3968-95 | 00121396895 | 1 TRAY in 1 CASE (0121-3968-95) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (0121-3968-74) | 1 tray | 2022-11-01 | 0000-00-00 | No | No | Current |