Fycompa (perampanel) NDC 69616-274

NDC codes

FDA NDC Directory

Product NDC (as listed)69616-274Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69616-0274Add 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 NDC	11-digit (billing)	Package
69616-274-14	69616027414	14 TABLET in 1 PACKAGE (69616-274-14)Marketed from Jan 2, 2024 · Sample package
69616-274-30	69616027430	30 TABLET in 1 BOTTLE (69616-274-30)Marketed from Jan 2, 2024
69616-274-90	69616027490	90 TABLET in 1 BOTTLE (69616-274-90)Marketed from Jan 2, 2024

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 — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Catalyst Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202834
Marketing start: Jan 2, 2024
Listing expires: Dec 31, 2026
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 69616-274_98f5e818-1e3f-43a8-9a56-9c44e639f431SPL ID 98f5e818-1e3f-43a8-9a56-9c44e639f431SPL set ID ec812ea3-de3a-4271-957c-db8f692d1ae3RxCUI 1356557, 1356563, 1356570, 1356572, 1356574, 1356576, 1356578, 1356580, 1356582, 1356584, 1356586, 1356588, 1790122, 1790126, 2641918, 2641919UNII H821664NPKUPC 0369616278303, 0369616276309, 0369616274305, 0369616280306, 0369616290381
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

N469616027414 followed by a unit qualifier and the quantity

Package 69616-0274-14. 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 Jan 5, 2024. 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-cloni…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202834

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

FDA NDC Directory listings under NDA 202834
Product	Strength	Form · route	Labeler	Product NDC
Fycompaperampanel	Perampanel 6 mg/1	TabletOral	Eisai Inc.	62856-276
Fycompaperampanel	Perampanel 2 mg/1	TabletOral	Eisai Inc.	62856-272
Fycompaperampanel	Perampanel 4 mg/1	TabletOral	Eisai Inc.	62856-274
Fycompaperampanel	Perampanel 8 mg/1	TabletOral	Eisai Inc.	62856-278
Fycompaperampanel	Perampanel 10 mg/1	TabletOral	Eisai Inc.	62856-280
Fycompaperampanel	Perampanel 12 mg/1	TabletOral	Eisai Inc.	62856-282
Fycompaperampanel	Perampanel 2 mg/1	TabletOral	Catalyst Pharmaceuticals, Inc.	69616-272
Fycompaperampanel	Perampanel 10 mg/1	TabletOral	Catalyst Pharmaceuticals, Inc.	69616-280
Fycompaperampanel	Perampanel 6 mg/1	TabletOral	Catalyst Pharmaceuticals, Inc.	69616-276
Fycompaperampanel	Perampanel 8 mg/1	TabletOral	Catalyst Pharmaceuticals, Inc.	69616-278
Fycompaperampanel	Perampanel 12 mg/1	TabletOral	Catalyst Pharmaceuticals, Inc.	69616-282