FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2458
11-digit product format
721622458
Labeler code
72162
Product ID
72162-2458_768d3b93-c1c6-4bf2-a4d8-cee017ab4a16
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
70 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 DIMESYLATE70 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854842

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
72162-2458-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2458-3LISDEXAMFETAMINE DIMESYLATE30 in 1 BOTTLECAPSULE30102
72162-2458-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2458-1EA - Each72162-245883bc0661-b7e6-4040-bb02-b94ec4ec37a912025-03-04
72162-2458-3EA - Each72162-24585a546286-e7c6-4ffe-a8f3-ae47803e3bd412025-03-04
72162-2458-9EA - Each72162-2458b46d02d6-90b4-42ba-ae3c-f41e14c15c0d12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2458LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250129_768d3b93-c1c6-4bf2-a4d8-cee017ab4a16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN768d3b93-c1c6-4bf2-a4d8-cee017ab4a16102
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD768d3b93-c1c6-4bf2-a4d8-cee017ab4a16102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2458-172162245801100 CAPSULE in 1 BOTTLE (72162-2458-1) 100 capsule2026-03-16NoNoHistorical
72162-2458-37216224580330 CAPSULE in 1 BOTTLE (72162-2458-3) 30 capsule2026-03-16NoNoHistorical
72162-2458-97216224580990 CAPSULE in 1 BOTTLE (72162-2458-9) 90 capsule2026-03-16NoNoHistorical