Home NDC 0480-7065 Perampanel
Product NDC 0480-7065
11-digit product format 004807065
Labeler code 0480
Product ID 0480-7065_d20021d0-2d19-4e8c-8ddb-9dbc0f6bca40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Perampanel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209801
Marketing category ANDA
Marketing start 2025-05-29
Substance PERAMPANEL
Active strength 6 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209801-001 PERAMPANEL PERAMPANEL 2MG TABLET / ORAL AB 2025-05-23 A209801-002 PERAMPANEL PERAMPANEL 4MG TABLET / ORAL AB 2025-05-23 A209801-003 PERAMPANEL PERAMPANEL 6MG TABLET / ORAL AB 2025-05-23 A209801-004 PERAMPANEL PERAMPANEL 8MG TABLET / ORAL AB 2025-05-23 A209801-005 PERAMPANEL PERAMPANEL 10MG TABLET / ORAL AB 2025-05-23 A209801-006 PERAMPANEL PERAMPANEL 12MG TABLET / ORAL AB 2025-05-23
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 2026-02-19 14:30 UTC 2026-02 A209801-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209801-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209801-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209801-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209801-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209801-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209801-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209801-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209801-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209801-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209801-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209801-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209801-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209801-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-05-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Perampanel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERAMPANEL 6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H821664NPK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1356557 Internal RxNorm lookup 1356570 Internal RxNorm lookup 1356574 Internal RxNorm lookup 1356578 Internal RxNorm lookup 1356582 Internal RxNorm lookup 1356586 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0480-7065-56 Perampanel 30 in 1 BOTTLE TABLET, FILM COATED 30 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-7065-56 00480706556 30 TABLET, FILM COATED in 1 BOTTLE (0480-7065-56) 2025-05-29 No No Current