FDA.reportPublic FDA data

Lisdexamfetamine dimesylate

Product NDC
0781-2476
11-digit product format
007812476
Labeler code
0781
Product ID
0781-2476_816921ba-16ab-4cdc-86e7-f21a86b03d1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA202836
Marketing category
ANDA
Marketing start
2025-09-16
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
20 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 DIMESYLATE20 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
0781-2476-01Lisdexamfetamine dimesylate100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2476-01EA - Each0781-24769afa60fe-4370-48af-9be1-eff13559638c12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD808cce3b-eee8-4f58-8d8a-53a4ce79ae7c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-2476-0100781247601100 CAPSULE in 1 BOTTLE (0781-2476-01) 100 capsule2025-09-16NoNoHistorical