FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
70010-211
11-digit product format
700100211
Labeler code
70010
Product ID
70010-211_51ac69ee-5739-024f-e063-6394a90a3179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISDEXAMFETAMINE DIMESYLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA218987
Marketing category
ANDA
Marketing start
2025-01-29
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
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 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
70010-211-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-211-01EA - Each70010-211b43f1bb7-5070-4771-a1d5-2588d67efaca12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-211LISDEXAMFETAMINE DIMESYLATE CAPSULE [GRANULES PHARMACEUTICALS INC.]1Current NDC, 1 package rows20250131_c91c6acf-b68c-4832-a06f-d0fbd6b80457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNc91c6acf-b68c-4832-a06f-d0fbd6b804573
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDc91c6acf-b68c-4832-a06f-d0fbd6b804573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-211-0170010021101100 CAPSULE in 1 BOTTLE (70010-211-01) 100 capsule2025-01-29NoNoCurrent