Fycompa

Product NDC: 69616-280
11-digit product format: 696160280
Labeler code: 69616
Product ID: 69616-280_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: 10 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
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.

Application-product, TE code table
Application-product	TE code
N202834-001	AB
N202834-002	AB
N202834-003	AB
N202834-004	AB
N202834-005	AB
N202834-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	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 · 246 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-005	FYCOMPA	10MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-006	FYCOMPA	12MG	TABLET / ORAL		RLD, RS	2012-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-001	FYCOMPA	2MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-002	FYCOMPA	4MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-003	FYCOMPA	6MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-004	FYCOMPA	8MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`

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	N202834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-006	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,416 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	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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	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	N202834-005	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	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	N202834-006	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	N202834-006	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	N202834-006	6949571	2025-05-23	U-2429	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	10 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.

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
2641918	Internal RxNorm lookup
2641919	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
ec812ea3-de3a-4271-957c-db8f692d1ae3	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
69616-280-30	Fycompa	30 in 1 BOTTLE	TABLET	30		4
69616-280-90	Fycompa	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69616-280-30	EA - Each	69616-280	bdafdbed-6408-4bc7-ad9c-172d668f98aa	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69616-280	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.

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): 202834 application number: NDA202834 ndc (product): 69616-280
Fycompa	PERAMPANEL	Eisai Inc.	71cf3309-e182-473c-8b0b-280cabd0e122	2022-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202834 application number: NDA202834

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
2641919	{14 (perampanel 2 MG Oral Tablet [FYCOMPA]) } Pack [Fycompa 2 MG 2-Week Sample Kit]	BPCK	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
2641918	{14 (perampanel 2 MG Oral Tablet) } Pack	GPCK	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790126	Fycompa 0.5 MG in 1 mL Oral Suspension	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356584	Fycompa 10 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356588	Fycompa 12 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
2641919	Fycompa 2 MG 2-Week Sample Kit	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356563	Fycompa 2 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356572	Fycompa 4 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356576	Fycompa 6 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356580	Fycompa 8 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790122	perampanel 0.5 MG in 1 mL Oral Suspension	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356582	perampanel 10 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356586	perampanel 12 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
2641918	perampanel 2 MG 2-Week Sample Kit	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356557	perampanel 2 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356570	perampanel 4 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356574	perampanel 6 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356578	perampanel 8 MG Oral Tablet	PSN	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790126	perampanel 0.5 MG/ML Oral Suspension [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356584	perampanel 10 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356588	perampanel 12 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356563	perampanel 2 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356572	perampanel 4 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356576	perampanel 6 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356580	perampanel 8 MG Oral Tablet [FYCOMPA]	SBD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790122	perampanel 0.5 MG/ML Oral Suspension	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356582	perampanel 10 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356586	perampanel 12 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356557	perampanel 2 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356570	perampanel 4 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356574	perampanel 6 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356578	perampanel 8 MG Oral Tablet	SCD	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790126	Fycompa 0.5 MG per 1 ML Oral Suspension	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356584	Fycompa 10 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356588	Fycompa 12 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
2641919	Fycompa 2 MG 2-Week Sample Kit	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356563	Fycompa 2 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356572	Fycompa 4 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356576	Fycompa 6 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1356580	Fycompa 8 MG Oral Tablet	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
1790122	perampanel 0.5 MG per 1 ML Oral Suspension	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4
2641918	perampanel 2 MG 2-Week Sample Kit	SY	ec812ea3-de3a-4271-957c-db8f692d1ae3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69616-280-30	69616028030	30 TABLET in 1 BOTTLE (69616-280-30)	30 tablet	2024-01-02	No	No	Current
69616-280-90	69616028090	90 TABLET in 1 BOTTLE (69616-280-90)	90 tablet	2024-01-02	No	No	Current