FDA.reportPublic FDA data

Lisdexamfetamine dimesylate

Product NDC
43547-607
11-digit product format
435470607
Labeler code
43547
Product ID
43547-607_c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine dimesylate capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare US,LLC
Application
ANDA216266
Marketing category
ANDA
Marketing start
2023-08-26
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
60 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 DIMESYLATE60 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
43547-607-10Lisdexamfetamine dimesylate100 in 1 BOTTLECAPSULE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-607LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE CAPSULES) CAPSULE [SOLCO HEALTHCARE US,LLC]3Current NDC, 1 package rows20240207_68b10d9f-ca3e-493d-a309-45f1d7e08061.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN68b10d9f-ca3e-493d-a309-45f1d7e080616
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD68b10d9f-ca3e-493d-a309-45f1d7e080616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-607-1043547060710100 CAPSULE in 1 BOTTLE (43547-607-10) 100 capsule2023-08-26NoNoCurrent