Home NDC 84386-085 Perampanel
Product NDC 84386-085
11-digit product format 843860085
Labeler code 84386
Product ID 84386-085_5fc14d5a-d0c2-4417-860d-e382c2d38e26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Perampanel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA220492
Marketing category ANDA
Marketing start 2026-10-02
Substance PERAMPANEL
Active strength 4 mg/1
Pharmacologic classes AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220492-001 PERAMPANEL PERAMPANEL 2MG TABLET / ORAL AB 2026-10-02 A220492-002 PERAMPANEL PERAMPANEL 4MG TABLET / ORAL AB 2026-10-02 A220492-003 PERAMPANEL PERAMPANEL 6MG TABLET / ORAL AB 2026-10-02 A220492-004 PERAMPANEL PERAMPANEL 8MG TABLET / ORAL AB 2026-10-02 A220492-005 PERAMPANEL PERAMPANEL 10MG TABLET / ORAL AB 2026-10-02 A220492-006 PERAMPANEL PERAMPANEL 12MG TABLET / ORAL AB 2026-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A220492-001 PERAMPANEL 2MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220492-002 PERAMPANEL 4MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220492-003 PERAMPANEL 6MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220492-004 PERAMPANEL 8MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220492-005 PERAMPANEL 10MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220492-006 PERAMPANEL 12MG TABLET / ORAL AB 2026-10-02 c2088c7a36db…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Perampanel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERAMPANEL 4 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84386-085-03 84386008503 3 BLISTER PACK in 1 CARTON (84386-085-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2026-10-02 No No Current 84386-085-30 84386008530 30 TABLET, FILM COATED in 1 BOTTLE (84386-085-30) 2026-10-02 No No Current