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NDC 00121-1012-95 Lacosamide 50 mg/5mL Details
Lacosamide 50 mg/5mL
Lacosamide is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is LACOSAMIDE.
MedlinePlus Drug Summary
Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 1 month of age and older. Lacosamide is also used in combination with other medications to control primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 4 years of age and older. Lacosamide is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 00121-1012-95Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Lacosamide
Product Information
| NDC | 00121-1012 |
|---|---|
| Product ID | 0121-1012_597d3a63-1ba4-4680-9329-dd60ef73fbaf |
| Associated GPIs | |
| GCN Sequence Number | 066386 |
| GCN Sequence Number Description | lacosamide SOLUTION 10 MG/ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 28643 |
| HICL Sequence Number | 035872 |
| HICL Sequence Number Description | LACOSAMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Lacosamide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lacosamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LACOSAMIDE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | CV |
| Marketing Category | ANDA |
| Application Number | ANDA216151 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-1012-95 (00121101295)
| NDC Package Code | 0121-1012-95 |
|---|---|
| Billing NDC | 00121101295 |
| Package | 1 TRAY in 1 CASE (0121-1012-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1012-05) |
| Marketing Start Date | 2023-04-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |