Prescription drug · ANDA
Perampanel NDC 0480-7065
Perampanel 6 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-7065-56 | 00480706556 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-7065-56)Marketed from May 29, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Perampanel
- Generic name (nonproprietary)
- perampanel
- Active ingredients
- Perampanel — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209801
- 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 0480-7065_0da0de2a-1896-49c3-b482-b7c83ac780bbSPL ID 0da0de2a-1896-49c3-b482-b7c83ac780bbSPL set ID bc8f7cf2-c19c-4235-859f-9ff1dd21908eRxCUI 1356557, 1356570, 1356574, 1356578, 1356582, 1356586UNII H821664NPKUPC 0304807067564, 0304807066567, 0304807062569
- 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
N400480706556followed by a unit qualifier and the quantityPackage 00480-7065-56. 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)
Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are 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 Perampanel tablets are 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 Perampanel tablets are indicated as adjunctive therapy for the treatmen…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209801
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 |
|---|---|---|---|---|
| Perampanel | Perampanel 4 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-7063 |
| Perampanel | Perampanel 8 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-7066 |
| Perampanel | Perampanel 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-7067 |
| Perampanel | Perampanel 12 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-7068 |
| Perampanel | Perampanel 2 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-7062 |