FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2456
11-digit product format
721622456
Labeler code
72162
Product ID
72162-2456_e23de82c-3edd-45b5-90f8-c2a7fe36e36d
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
50 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 DIMESYLATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854850

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
72162-2456-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2456-3LISDEXAMFETAMINE DIMESYLATE30 in 1 BOTTLECAPSULE30102
72162-2456-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2456-1EA - Each72162-2456e837c133-ffd7-4e84-acae-e3f6bb0e99a112025-03-04
72162-2456-3EA - Each72162-245653366c0e-2e63-4ec2-b753-6a798e4e341a12025-03-04
72162-2456-9EA - Each72162-24567a476065-a7ce-4e40-899d-c722fb88839e12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2456LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250129_18a97c88-0f72-4b02-be0d-4d093886cca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN18a97c88-0f72-4b02-be0d-4d093886cca5102
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD18a97c88-0f72-4b02-be0d-4d093886cca5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2456-172162245601100 CAPSULE in 1 BOTTLE (72162-2456-1) 100 capsule2026-03-16NoNoHistorical
72162-2456-37216224560330 CAPSULE in 1 BOTTLE (72162-2456-3) 30 capsule2026-03-16NoNoHistorical
72162-2456-97216224560990 CAPSULE in 1 BOTTLE (72162-2456-9) 90 capsule2026-03-16NoNoHistorical