LACOSAMIDE
- Product NDC
- 69543-455
- 11-digit product format
- 695430455
- Labeler code
- 69543
- Product ID
- 69543-455_21cd2911-f9de-4d64-b2b3-409a8eb01b8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACOSAMIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Virtus Pharmaceuticals, LLC
- Application
- ANDA215628
- Marketing category
- ANDA
- Marketing start
- 2023-04-17
- Marketing end
- 2027-09-30
- Substance
- LACOSAMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- DEA schedule
- CV
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LACOSAMIDE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACOSAMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 809974 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69543-455-10 | LACOSAMIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 69543-455-20 | LACOSAMIDE | 20 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69543-455 | LACOSAMIDE INJECTION, SOLUTION [VIRTUS PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230419_01162e2f-967b-4596-8188-c0d9889c3814.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 |
|---|
| 69543-455-10 | 69543045510 | 10 VIAL, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20) | | 2023-04-17 | 2027-09-30 | No | No | Historical |
| 69543-455-20 | 69543045520 | 20 mL in 1 VIAL, GLASS | 20 ml | | | | | Historical |