NDC codes

FDA NDC Directory
Product NDC (as listed)62856-290Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62856-0290Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
62856-290-3862856029038340 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

N462856029038 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208277

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208277
ProductStrengthForm · routeLabelerProduct NDC
FycompaperampanelPerampanel .5 mg/mLSuspensionOralCatalyst Pharmaceuticals, Inc.69616-290

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