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NDC 69616-0280-90 Fycompa 10 mg/1 Details
Fycompa 10 mg/1
Fycompa is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Catalyst Pharmaceuticals, Inc.. The primary component is PERAMPANEL.
MedlinePlus Drug Summary
Perampanel is used to treat certain types of partial onset seizures (seizures that involve only one part of the brain) in adults and children 4 years of age and older. It is also used in combination with other medications to treat certain types of primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 12 years of age or older. Perampanel is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 69616-0280-90Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Perampanel
Product Information
| NDC | 69616-0280 |
|---|---|
| Product ID | 69616-280_98f5e818-1e3f-43a8-9a56-9c44e639f431 |
| Associated GPIs | |
| GCN Sequence Number | 069992 |
| GCN Sequence Number Description | perampanel TABLET 10 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 33275 |
| HICL Sequence Number | 039628 |
| HICL Sequence Number Description | PERAMPANEL |
| Brand/Generic | Brand |
| Proprietary Name | Fycompa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | perampanel |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | PERAMPANEL |
| Labeler Name | Catalyst Pharmaceuticals, Inc. |
| Pharmaceutical Class | AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA202834 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 69616-0280-90 (69616028090)
| NDC Package Code | 69616-280-90 |
|---|---|
| Billing NDC | 69616028090 |
| Package | 90 TABLET in 1 BOTTLE (69616-280-90) |
| Marketing Start Date | 2024-01-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |