PERAMPANEL

Product NDC
72205-071
11-digit product format
722050071
Labeler code
72205
Product ID
72205-071_4d8be129-f3cb-49ad-ae5a-a74a50dff689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PERAMPANEL
Dosage form
SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218152
Marketing category
ANDA
Marketing start
2025-07-11
Substance
PERAMPANEL
Active strength
.5 mg/mL
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
PERAMPANEL.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH821664NPK
Rxcui1790122

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
72205-071-79PERAMPANEL340 mL in 1 BOTTLESUSPENSION3401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-071-79ML - Milliliter72205-0714ee1eb5e-3ce1-4374-8c05-7187a824fa7412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790122perampanel 0.5 MG in 1 mL Oral SuspensionPSN4d8be129-f3cb-49ad-ae5a-a74a50dff6891
1790122perampanel 0.5 MG/ML Oral SuspensionSCD4d8be129-f3cb-49ad-ae5a-a74a50dff6891
1790122perampanel 0.5 MG per 1 ML Oral SuspensionSY4d8be129-f3cb-49ad-ae5a-a74a50dff6891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-071-7972205007179340 mL in 1 BOTTLE (72205-071-79) 340 ml2025-12-15NoNoHistorical