FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0378-6859
11-digit product format
003786859
Labeler code
0378
Product ID
0378-6859_63cd6f7c-f976-440e-a35f-e71a9f2fd1bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202835
Marketing category
ANDA
Marketing start
2023-08-25
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
0378-6859-77Lisdexamfetamine Dimesylate90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6859-77EA - Each0378-6859e343533d-de8a-427e-b5cb-3e619f48c17a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6859LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [MYLAN PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240410_efbde0f6-b848-4664-b741-c6c630e66108.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0378-6859-770037868597790 CAPSULE in 1 BOTTLE, PLASTIC (0378-6859-77) 90 capsule2023-08-25NoNoHistorical