LACOSAMIDE
- Product NDC
- 68094-176
- 11-digit product format
- 680940176
- Labeler code
- 68094
- Product ID
- 68094-176_ecaaaf34-a01b-4160-951b-47f72c4b5d9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACOSAMIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA216461
- Marketing category
- ANDA
- Marketing start
- 2025-09-22
- 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 |
|---|
| 68094-176-59 | LACOSAMIDE | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 1 |
| 68094-176-62 | LACOSAMIDE | 3 in 1 CASE | SOLUTION | 3 | | 1 |
| 68094-176-62 | LACOSAMIDE | 10 in 1 TRAY | SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-176-59 | 68094017659 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 68094-176-62 | 68094017662 | 3 TRAY in 1 CASE (68094-176-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-176-59) | 3 tray | 2025-09-22 | No | No | Historical |