LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2457
11-digit product format
721622457
Labeler code
72162
Product ID
72162-2457_06da0212-6b2d-445f-8056-13019325ca88
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
60 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 DIMESYLATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854846

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
72162-2457-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2457-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2457-1EA - Each72162-24577e8bf055-615e-45aa-a66c-d22985b4903d12025-03-04
72162-2457-9EA - Each72162-2457a5aa918e-2eea-48c7-a858-593389662d1912025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2457LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250129_281842ea-d165-4b6d-a366-791239be8c2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN281842ea-d165-4b6d-a366-791239be8c2e102
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD281842ea-d165-4b6d-a366-791239be8c2e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2457-172162245701100 CAPSULE in 1 BOTTLE (72162-2457-1) 100 capsule2026-03-16NoNoHistorical
72162-2457-97216224570990 CAPSULE in 1 BOTTLE (72162-2457-9) 90 capsule2026-03-16NoNoHistorical