Home NDC 69616-282 Fycompa
Product NDC 69616-282
11-digit product format 696160282
Labeler code 69616
Product ID 69616-282_98f5e818-1e3f-43a8-9a56-9c44e639f431
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name perampanel
Dosage form TABLET
Route ORAL
Labeler Catalyst Pharmaceuticals, Inc.
Application NDA202834
Marketing category NDA
Marketing start 2024-01-02
Substance PERAMPANEL
Active strength 12 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 42 .
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 N202834-001 FYCOMPA PERAMPANEL 2MG TABLET / ORAL AB RLD 2012-10-22 N202834-002 FYCOMPA PERAMPANEL 4MG TABLET / ORAL AB RLD 2012-10-22 N202834-003 FYCOMPA PERAMPANEL 6MG TABLET / ORAL AB RLD 2012-10-22 N202834-004 FYCOMPA PERAMPANEL 8MG TABLET / ORAL AB RLD 2012-10-22 N202834-005 FYCOMPA PERAMPANEL 10MG TABLET / ORAL AB RLD 2012-10-22 N202834-006 FYCOMPA PERAMPANEL 12MG TABLET / ORAL AB RLD, RS 2012-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202834-001 8772497 2026-07-01 Drug substance 2014-08-06 N202834-002 8772497 2026-07-01 Drug substance 2014-08-06 N202834-003 8772497 2026-07-01 Drug substance 2014-08-06 N202834-004 8772497 2026-07-01 Drug substance 2014-08-06 N202834-005 8772497 2026-07-01 Drug substance 2014-08-06 N202834-006 8772497 2026-07-01 Drug substance 2014-08-06
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.
Product history page 1 of 7 · 252 observed 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 2026-08-18 06:07:40 2026-07 N202834-001 FYCOMPA 2MG TABLET / ORAL AB RLD 2012-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-002 FYCOMPA 4MG TABLET / ORAL AB RLD 2012-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-003 FYCOMPA 6MG TABLET / ORAL AB RLD 2012-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-004 FYCOMPA 8MG TABLET / ORAL AB RLD 2012-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-005 FYCOMPA 10MG TABLET / ORAL AB RLD 2012-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-006 FYCOMPA 12MG TABLET / ORAL AB RLD, RS 2012-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202834-001 FYCOMPA 2MG TABLET / ORAL AB RLD 2012-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-002 FYCOMPA 4MG TABLET / ORAL AB RLD 2012-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-003 FYCOMPA 6MG TABLET / ORAL AB RLD 2012-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-004 FYCOMPA 8MG TABLET / ORAL AB RLD 2012-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-005 FYCOMPA 10MG TABLET / ORAL AB RLD 2012-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-006 FYCOMPA 12MG TABLET / ORAL AB RLD, RS 2012-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 FYCOMPA 2MG TABLET / ORAL AB RLD 2012-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 FYCOMPA 4MG TABLET / ORAL AB RLD 2012-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 FYCOMPA 6MG TABLET / ORAL AB RLD 2012-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 FYCOMPA 8MG TABLET / ORAL AB RLD 2012-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-005 FYCOMPA 10MG TABLET / ORAL AB RLD 2012-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-006 FYCOMPA 12MG TABLET / ORAL AB RLD, RS 2012-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202834-001 FYCOMPA 2MG TABLET / ORAL AB RLD 2012-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202834-002 FYCOMPA 4MG TABLET / ORAL AB RLD 2012-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202834-003 FYCOMPA 6MG TABLET / ORAL AB RLD 2012-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202834-004 FYCOMPA 8MG TABLET / ORAL AB RLD 2012-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202834-005 FYCOMPA 10MG TABLET / ORAL AB RLD 2012-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202834-006 FYCOMPA 12MG TABLET / ORAL AB RLD, RS 2012-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-001 FYCOMPA 2MG TABLET / ORAL RLD 2012-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-002 FYCOMPA 4MG TABLET / ORAL RLD 2012-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-003 FYCOMPA 6MG TABLET / ORAL RLD 2012-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-004 FYCOMPA 8MG TABLET / ORAL RLD 2012-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-005 FYCOMPA 10MG TABLET / ORAL RLD 2012-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202834-006 FYCOMPA 12MG TABLET / ORAL RLD, RS 2012-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-001 FYCOMPA 2MG TABLET / ORAL RLD 2012-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-002 FYCOMPA 4MG TABLET / ORAL RLD 2012-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-003 FYCOMPA 6MG TABLET / ORAL RLD 2012-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-004 FYCOMPA 8MG TABLET / ORAL RLD 2012-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-005 FYCOMPA 10MG TABLET / ORAL RLD 2012-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202834-006 FYCOMPA 12MG TABLET / ORAL RLD, RS 2012-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202834-001 FYCOMPA 2MG TABLET / ORAL RLD 2012-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202834-002 FYCOMPA 4MG TABLET / ORAL RLD 2012-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202834-003 FYCOMPA 6MG TABLET / ORAL RLD 2012-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202834-004 FYCOMPA 8MG TABLET / ORAL RLD 2012-10-22 03ed91905a0d…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 36 · 1,422 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N202834-001 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-002 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-003 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-004 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-005 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202834-006 8772497 2026-07-01 Drug substance 2014-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202834-001 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-002 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-003 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-004 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-005 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202834-006 8772497 2026-07-01 Drug substance 2014-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 6949571 2025-05-23 U-2429 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 6949571 2025-05-23 U-2428 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 6949571 2025-05-23 U-2089 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 6949571 2025-05-23 U-106 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 6949571 2025-05-23 U-2088 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-001 8772497 2026-07-01 Drug substance 2014-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 6949571 2025-05-23 U-2088 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 6949571 2025-05-23 U-2089 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 6949571 2025-05-23 U-2428 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 6949571 2025-05-23 U-2429 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 6949571 2025-05-23 U-106 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-002 8772497 2026-07-01 Drug substance 2014-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 6949571 2025-05-23 U-2088 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 6949571 2025-05-23 U-106 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 6949571 2025-05-23 U-2429 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 6949571 2025-05-23 U-2428 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 6949571 2025-05-23 U-2089 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-003 8772497 2026-07-01 Drug substance 2014-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 6949571 2025-05-23 U-2428 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 6949571 2025-05-23 U-2089 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 6949571 2025-05-23 U-2429 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 6949571 2025-05-23 U-106 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 6949571 2025-05-23 U-2088 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-004 8772497 2026-07-01 Drug substance 2014-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-005 6949571 2025-05-23 U-2428 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-005 6949571 2025-05-23 U-2088 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-005 6949571 2025-05-23 U-2429 Drug substance, Drug product 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202834-005 6949571 2025-05-23 U-2089 Drug substance, Drug product 2012-11-19 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base Fycompa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERAMPANEL 12 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 · 16 matching rows.
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 69616-282-30 Fycompa 30 in 1 BOTTLE TABLET 30 4 69616-282-90 Fycompa 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69616-282 FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [CATALYST PHARMACEUTICALS, INC.] 4 Current NDC, 2 package rows 20240106_ec812ea3-de3a-4271-957c-db8f692d1ae3.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69616-282-30 69616028230 30 TABLET in 1 BOTTLE (69616-282-30) 30 tablet 2024-01-02 No No Current 69616-282-90 69616028290 90 TABLET in 1 BOTTLE (69616-282-90) 90 tablet 2024-01-02 No No Current