Prescription drug · NDA
Fycompa (perampanel) NDC 62856-290
Perampanel .5 mg/mL · Suspension · Oral · Eisai Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62856-290-38 | 62856029038 | 340 mL in 1 BOTTLE (62856-290-38)Marketed from Apr 30, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fycompa
- Generic name (nonproprietary)
- perampanel
- Active ingredients
- Perampanel — .5 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Eisai Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208277
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- AMPA Receptor Antagonists (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)UGT2B7 Inhibitors (Mechanism)
- Identifiers
- Product ID 62856-290_57623abc-0527-46c7-9046-4e4d077edbadSPL ID 57623abc-0527-46c7-9046-4e4d077edbadSPL set ID 71cf3309-e182-473c-8b0b-280cabd0e122RxCUI 1356557, 1356563, 1356570, 1356572, 1356574, 1356576, 1356578, 1356580, 1356582, 1356584, 1356586, 1356588, 1790122, 1790126UNII H821664NPKUPC 0362856278300, 0362856243902, 0362856274302, 0362856272308, 0362856276306, 0362856282307, 0362856280303
- Pharmacologic class
- Noncompetitive AMPA Glutamate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N462856029038followed by a unit qualifier and the quantityPackage 62856-0290-38. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 ) 1.1 Partial - Onset Seizures FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clo…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208277
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fycompaperampanel | Perampanel .5 mg/mL | SuspensionOral | Catalyst Pharmaceuticals, Inc. | 69616-290 |