Perampanel

Product NDC
0480-7062
11-digit product format
004807062
Labeler code
0480
Product ID
0480-7062_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
2 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
PERAMPANEL2 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-7062-56Perampanel30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-7062-56EA - Each0480-7062000cd053-b7fe-45b7-86cc-9c2ad7f6d79e12025-06-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1356582perampanel 10 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356586perampanel 12 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356557perampanel 2 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356570perampanel 4 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356574perampanel 6 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356578perampanel 8 MG Oral TabletPSNbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356582perampanel 10 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356586perampanel 12 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356557perampanel 2 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356570perampanel 4 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356574perampanel 6 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3
1356578perampanel 8 MG Oral TabletSCDbc8f7cf2-c19c-4235-859f-9ff1dd21908e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-7062-560048070625630 TABLET, FILM COATED in 1 BOTTLE (0480-7062-56) 2025-05-29NoNoCurrent