Perampanel

Product NDC
72205-225
11-digit product format
722050225
Labeler code
72205
Product ID
72205-225_695c8c73-39cb-4927-bdf6-72d16e4aa9bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perampanel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218178
Marketing category
ANDA
Marketing start
2025-11-25
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERAMPANEL10 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
72205-225-30Perampanel30 in 1 BOTTLETABLET, FILM COATED301
72205-225-90Perampanel90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-225-30EA - Each72205-225d6305ebe-41a1-4fed-a3e9-b250d605671812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1356582perampanel 10 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356586perampanel 12 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356557perampanel 2 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356570perampanel 4 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356574perampanel 6 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356578perampanel 8 MG Oral TabletPSN695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356582perampanel 10 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356586perampanel 12 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356557perampanel 2 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356570perampanel 4 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356574perampanel 6 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1
1356578perampanel 8 MG Oral TabletSCD695c8c73-39cb-4927-bdf6-72d16e4aa9bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-225-307220502253030 TABLET, FILM COATED in 1 BOTTLE (72205-225-30) 2025-11-26NoNoCurrent
72205-225-907220502259090 TABLET, FILM COATED in 1 BOTTLE (72205-225-90) 2025-11-26NoNoCurrent