LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2455
11-digit product format
721622455
Labeler code
72162
Product ID
72162-2455_5ace65d7-b72d-477b-9568-f2e8188ebcf4
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
40 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 DIMESYLATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854838

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
72162-2455-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2455-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2455-1EA - Each72162-2455cf395726-9334-4cb6-81b2-96129abe195612025-03-04
72162-2455-9EA - Each72162-2455bde60ec6-381d-4c9d-8f35-2978e74c776e12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2455LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250129_483cc379-fd34-45aa-a5c0-09c4d0c167d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN483cc379-fd34-45aa-a5c0-09c4d0c167d9102
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD483cc379-fd34-45aa-a5c0-09c4d0c167d9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2455-172162245501100 CAPSULE in 1 BOTTLE (72162-2455-1) 100 capsule2026-03-16NoNoHistorical
72162-2455-97216224550990 CAPSULE in 1 BOTTLE (72162-2455-9) 90 capsule2026-03-16NoNoHistorical