Lacosamide
- Product NDC
- 70954-488
- 11-digit product format
- 709540488
- Labeler code
- 70954
- Product ID
- 70954-488_8b5b4014-2795-4ebd-b53e-1157a2c0b98a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA216151
- Marketing category
- ANDA
- Marketing start
- 2022-08-26
- Substance
- LACOSAMIDE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
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 |
|---|
| 70954-488-10 | Lacosamide | 200 mL in 1 BOTTLE, PLASTIC | SOLUTION | 200 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-488 | LACOSAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250119_68033c90-d9cc-4d5f-896c-9a61a0c3b529.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 |
|---|
| 70954-488-10 | 70954048810 | 200 mL in 1 BOTTLE, PLASTIC (70954-488-10) | 200 ml | 2022-08-26 | 0000-00-00 | No | No | Current |