FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0527-4664
11-digit product format
005274664
Labeler code
0527
Product ID
0527-4664_cb49954d-0f9d-4471-bc86-0c926473c00b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine Dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA215802
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
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
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
0527-4664-37Lisdexamfetamine Dimesylate100 in 1 BOTTLECAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-4664-37EA - Each0527-4664dae6fbbf-cb56-44f7-8ceb-1ee2e9db16db12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4664LISDEXAMFETAMINE DIMESYLATE CAPSULE [LANNETT COMPANY, INC.]17Current NDC, 1 package rows20231110_2cedb4c2-1e40-4bc4-b9f4-127150c4afbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-4664-3700527466437100 CAPSULE in 1 BOTTLE (0527-4664-37) 100 capsule2023-08-25NoNoHistorical