Fycompa

Product NDC: 62856-290
11-digit product format: 628560290
Labeler code: 62856
Product ID: 62856-290_57623abc-0527-46c7-9046-4e4d077edbad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: perampanel
Dosage form: SUSPENSION
Route: ORAL
Labeler: Eisai Inc.
Application: NDA208277
Marketing category: NDA
Marketing start: 2016-04-30
Substance: PERAMPANEL
Active strength: .5 mg/mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208277-001	FYCOMPA	PERAMPANEL	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N208277-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208277-001	8772497	2026-07-01		Drug substance	2016-05-27

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208277-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208277-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208277-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 236 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fycompa
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PERAMPANEL	.5 mg/mL

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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1356557	Internal RxNorm lookup
1356563	Internal RxNorm lookup
1356570	Internal RxNorm lookup
1356572	Internal RxNorm lookup
1356574	Internal RxNorm lookup
1356576	Internal RxNorm lookup
1356578	Internal RxNorm lookup
1356580	Internal RxNorm lookup
1356582	Internal RxNorm lookup
1356584	Internal RxNorm lookup
1356586	Internal RxNorm lookup
1356588	Internal RxNorm lookup
1790122	Internal RxNorm lookup
1790126	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71cf3309-e182-473c-8b0b-280cabd0e122	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
936a5710-8aab-7641-c7fe-d3c90f538696	Product name	3	20260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62856-290-38	Fycompa	340 mL in 1 BOTTLE	SUSPENSION	340		60

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-290-38	ML - Milliliter	62856-290	7bbb6ede-6e15-4fea-9dba-089eb453544a	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PERAMPANEL	ACTIVE INGREDIENT	H821664NPK	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
PERAMPANEL	ACTIVE MOIETY	H821664NPK	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FYCOMPA (PERAMPANEL) KIT FYCOMPA (PERAMPANEL) TABLET [EISAI INC.]	25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62856-290	FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [EISAI INC.]	58	Current NDC, Legacy NDC, 1 package rows	20231126_71cf3309-e182-473c-8b0b-280cabd0e122.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fycompa	PERAMPANEL	Catalyst Pharmaceuticals, Inc.	ec812ea3-de3a-4271-957c-db8f692d1ae3	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208277 application number: NDA208277
Fycompa	PERAMPANEL	Eisai Inc.	71cf3309-e182-473c-8b0b-280cabd0e122	2022-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208277 application number: NDA208277 ndc (product): 62856-290

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H821664NPK	PERAMPANEL	380917-97-5	PERAMPANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790126	Fycompa 0.5 MG in 1 mL Oral Suspension	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356584	Fycompa 10 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356588	Fycompa 12 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356563	Fycompa 2 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356572	Fycompa 4 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356576	Fycompa 6 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356580	Fycompa 8 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1790122	perampanel 0.5 MG in 1 mL Oral Suspension	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356582	perampanel 10 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356586	perampanel 12 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356557	perampanel 2 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356570	perampanel 4 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356574	perampanel 6 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356578	perampanel 8 MG Oral Tablet	PSN	71cf3309-e182-473c-8b0b-280cabd0e122	60
1790126	perampanel 0.5 MG/ML Oral Suspension [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356584	perampanel 10 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356588	perampanel 12 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356563	perampanel 2 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356572	perampanel 4 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356576	perampanel 6 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356580	perampanel 8 MG Oral Tablet [FYCOMPA]	SBD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1790122	perampanel 0.5 MG/ML Oral Suspension	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356582	perampanel 10 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356586	perampanel 12 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356557	perampanel 2 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356570	perampanel 4 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356574	perampanel 6 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356578	perampanel 8 MG Oral Tablet	SCD	71cf3309-e182-473c-8b0b-280cabd0e122	60
1790126	Fycompa 0.5 MG per 1 ML Oral Suspension	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356584	Fycompa 10 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356588	Fycompa 12 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356563	Fycompa 2 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356572	Fycompa 4 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356576	Fycompa 6 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1356580	Fycompa 8 MG Oral Tablet	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60
1790122	perampanel 0.5 MG per 1 ML Oral Suspension	SY	71cf3309-e182-473c-8b0b-280cabd0e122	60

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62856-290-38	62856029038	340 mL in 1 BOTTLE (62856-290-38)	340 ml	2016-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fycompa	Eisai Inc. \| Delpharm Huningue \| Eisai Co., Ltd. \| Eisai Manufacturing Ltd \| F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. \| Pace Analytical Life Sciences, LLC \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	60