Perampanel

Product NDC
0480-7066
11-digit product format
004807066
Labeler code
0480
Product ID
0480-7066_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
8 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H821664NPKPERAMPANEL380917-97-5PERAMPANEL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-7066-560048070665630 TABLET, FILM COATED in 1 BOTTLE (0480-7066-56) 2025-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PerampanelTeva Pharmaceuticals, Inc.2024-09-27HUMAN PRESCRIPTION DRUG LABEL3