FDA.reportPublic FDA data

lisdexamfetamine dimesylate

Product NDC
47781-565
11-digit product format
477810565
Labeler code
47781
Product ID
47781-565_567bb281-4098-07f8-9503-92299dc1c4c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA214547
Marketing category
ANDA
Marketing start
2023-08-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
lisdexamfetamine dimesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854830, 854834, 854838, 854842, 854846, 854850, 1593856

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
47781-565-01lisdexamfetamine dimesylate100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-565-01EA - Each47781-5658b7566bb-669f-4797-a4b4-774a9af8b23812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-565LISDEXAMFETAMINE DIMESYLATE CAPSULE [ALVOGEN INC.]3Current NDC, 1 package rows20250425_7f2dd6ee-3363-c87c-9693-ed838942556c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN7f2dd6ee-3363-c87c-9693-ed838942556c4
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD7f2dd6ee-3363-c87c-9693-ed838942556c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
47781-565-0147781056501100 CAPSULE in 1 BOTTLE (47781-565-01) 100 capsule2023-08-25NoNoHistorical