LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2452
11-digit product format
721622452
Labeler code
72162
Product ID
72162-2452_b41b15a1-e7fa-40bf-b395-aff2b3aee74a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISDEXAMFETAMINE DIMESYLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215330
Marketing category
ANDA
Marketing start
2024-01-30
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
20 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISDEXAMFETAMINE DIMESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854830

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb29ac3a-860f-7ed2-7559-c97af4af1704Product name320250603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2452-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2452-3LISDEXAMFETAMINE DIMESYLATE30 in 1 BOTTLECAPSULE30102
72162-2452-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2452LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250129_5eab8a4f-0438-4f5c-8f32-53cc98ea134b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN5eab8a4f-0438-4f5c-8f32-53cc98ea134b102
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD5eab8a4f-0438-4f5c-8f32-53cc98ea134b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2452-172162245201100 CAPSULE in 1 BOTTLE (72162-2452-1) 100 capsule2026-03-16NoNoCurrent
72162-2452-37216224520330 CAPSULE in 1 BOTTLE (72162-2452-3) 30 capsule2026-03-16NoNoCurrent
72162-2452-97216224520990 CAPSULE in 1 BOTTLE (72162-2452-9) 90 capsule2026-03-16NoNoCurrent