FDA.reportPublic FDA data

Perampanel

Product NDC
51672-4205
11-digit product format
516724205
Labeler code
51672
Product ID
51672-4205_4653e298-d84f-dc92-e063-6294a90a2d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perampanel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209538
Marketing category
ANDA
Marketing start
2025-11-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Perampanel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERAMPANEL4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH821664NPK
Rxcui1356557, 1356570, 1356574, 1356578, 1356582, 1356586

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
936a5710-8aab-7641-c7fe-d3c90f538696Product name320260306
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4205-2Perampanel10 in 1 BLISTER PACKTABLET, FILM COATED104
51672-4205-2Perampanel3 in 1 CARTONTABLET, FILM COATED34
51672-4205-6Perampanel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4205-6EA - Each51672-4205bd41b95f-5c78-43df-9e00-771e98a016d212025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1356582perampanel 10 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356586perampanel 12 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356557perampanel 2 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356570perampanel 4 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356574perampanel 6 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356578perampanel 8 MG Oral TabletPSN1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356582perampanel 10 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356586perampanel 12 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356557perampanel 2 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356570perampanel 4 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356574perampanel 6 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104
1356578perampanel 8 MG Oral TabletSCD1b0458ea-e718-4d48-ae55-ad9b4d8638104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-4205-2516724205023 BLISTER PACK in 1 CARTON (51672-4205-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2025-11-25NoNoHistorical
51672-4205-65167242050630 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4205-6) 2025-11-25NoNoHistorical