LISDEXAMFETAMINE DIMESYLATE

Product NDC
60687-951
11-digit product format
606870951
Labeler code
60687
Product ID
60687-951_451268f8-06c6-cbff-e063-6394a90a5625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA217442
Marketing category
ANDA
Marketing start
2025-12-01
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
70 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 DIMESYLATE70 mg/1

Harmonized Identifiers#

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

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
60687-951-11LISDEXAMFETAMINE DIMESYLATE1 in 1 BLISTER PACKCAPSULE11
60687-951-21LISDEXAMFETAMINE DIMESYLATE30 in 1 CARTONCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-951-11EA - Each60687-9512805cd79-d646-4226-a06e-9cc6caf9c27912025-12-16
60687-951-21EA - Each60687-951dcacdde7-7c96-4e77-9f3e-56ae67b7c76412025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-951-11606870951111 in 1 BLISTER PACKHistorical
60687-951-216068709512130 BLISTER PACK in 1 CARTON (60687-951-21) / 1 CAPSULE in 1 BLISTER PACK (60687-951-11) 30 blister pack2025-12-01NoNoHistorical