FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2454
11-digit product format
721622454
Labeler code
72162
Product ID
72162-2454_8fbaf129-72b7-426f-9222-b6c21f3bf583
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
30 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 DIMESYLATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854834

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
72162-2454-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2454-3LISDEXAMFETAMINE DIMESYLATE30 in 1 BOTTLECAPSULE30102
72162-2454-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2454-1EA - Each72162-2454401f6bf1-c674-42d2-9585-51faf39682b712025-03-04
72162-2454-3EA - Each72162-24542a4aee9b-4239-45d9-a048-447f7827cab712025-03-04
72162-2454-9EA - Each72162-2454ae37fadd-1f88-4840-8cd4-850bc92f88b012025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2454LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250129_b548020c-dd53-4929-96d6-175a78eba5bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNb548020c-dd53-4929-96d6-175a78eba5bb102
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDb548020c-dd53-4929-96d6-175a78eba5bb102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2454-172162245401100 CAPSULE in 1 BOTTLE (72162-2454-1) 100 capsule2026-03-16NoNoHistorical
72162-2454-37216224540330 CAPSULE in 1 BOTTLE (72162-2454-3) 30 capsule2026-03-16NoNoHistorical
72162-2454-97216224540990 CAPSULE in 1 BOTTLE (72162-2454-9) 90 capsule2026-03-16NoNoHistorical