FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
72162-2451
11-digit product format
721622451
Labeler code
72162
Product ID
72162-2451_903eb712-e3ac-4165-a87a-2fa231c21462
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
10 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 DIMESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui1593856

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
72162-2451-1LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE100102
72162-2451-9LISDEXAMFETAMINE DIMESYLATE90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2451-1EA - Each72162-24515f4742c8-a17b-4a63-8aa4-46e77e96c0e812025-03-04
72162-2451-9EA - Each72162-2451b7e8c0e1-1959-4840-b301-39f8c901e1ca12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2451LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250129_3b69003f-f7b4-4e52-acde-4b229d6c51fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN3b69003f-f7b4-4e52-acde-4b229d6c51fe102
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD3b69003f-f7b4-4e52-acde-4b229d6c51fe102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2451-172162245101100 CAPSULE in 1 BOTTLE (72162-2451-1) 100 capsule2026-03-16NoNoHistorical
72162-2451-97216224510990 CAPSULE in 1 BOTTLE (72162-2451-9) 90 capsule2026-03-16NoNoHistorical