Prescription drug · ANDA
Perampanel NDC 84386-089
Perampanel 12 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-089-03 | 8438600890384386008903 | 3 BLISTER PACK in 1 CARTON (84386-089-03) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 2, 2026 | |
| 84386-089-30 | 8438600893084386008930 | 30 TABLET, FILM COATED in 1 BOTTLE (84386-089-30)Marketed from Oct 2, 2026 |
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)
- Perampanel
- Generic name (nonproprietary)
- perampanel
- Active ingredients
- Perampanel — 12 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 84386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220492
- 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 84386-089_5fc14d5a-d0c2-4417-860d-e382c2d38e26SPL ID 5fc14d5a-d0c2-4417-860d-e382c2d38e26
- 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
N484386008903followed by a unit qualifier and the quantityPackage 84386-0089-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 84386-089
- What is NDC 84386-089?
- 84386-089 is the product NDC for Perampanel, Perampanel 12 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Perampanel.
- What is the active ingredient?
- Perampanel.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 84386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Perampanel?
- 25 other product NDCs are listed under this name. See all Perampanel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Perampanel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Perampanel | Perampanel 2 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-084 | 84386-0084-0384386-0084-30 |
| Perampanel | Perampanel 4 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-085 | 84386-0085-0384386-0085-30 |
| Perampanel | Perampanel 6 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-086 | 84386-0086-0384386-0086-30 |
| Perampanel | Perampanel 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-087 | 84386-0087-0384386-0087-30 |
| Perampanel | Perampanel 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-088 | 84386-0088-0384386-0088-30 |
| Perampanel | Perampanel .5 mg/mL | SuspensionOral | Sun Pharmaceutical Industries, Inc. | 51672-4256 | 51672-4256-09 |
| Perampanel | Perampanel 2 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4204 | 51672-4204-0351672-4204-06 |
| Perampanel | Perampanel 4 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4205 | 51672-4205-0251672-4205-06 |
| Perampanel | Perampanel 6 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4206 | 51672-4206-0251672-4206-06 |
| Perampanel | Perampanel 8 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4207 | 51672-4207-0251672-4207-06 |
Other NDCs under ANDA 220492
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 2 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-084 |
| Perampanel | Perampanel 4 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-085 |
| Perampanel | Perampanel 6 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-086 |
| Perampanel | Perampanel 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-087 |
| Perampanel | Perampanel 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-088 |