FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
31722-352
11-digit product format
317220352
Labeler code
31722
Product ID
31722-352_c797bf2e-e9b6-4f7f-b12c-c514667107f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217442
Marketing category
ANDA
Marketing start
2024-09-09
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
30 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS

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
31722-352-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-352-01EA - Each31722-35280d13181-5e16-4c4d-875c-31aba2f1c12612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-352LISDEXAMFETAMINE DIMESYLATE CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240925_20baa61e-be0b-41a3-a896-29e8ce8c4799.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN20baa61e-be0b-41a3-a896-29e8ce8c47991
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNe928c7e6-c889-4854-a9c1-e23fb860ba8e1
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD20baa61e-be0b-41a3-a896-29e8ce8c47991
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDe928c7e6-c889-4854-a9c1-e23fb860ba8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-352-0131722035201100 CAPSULE in 1 BOTTLE (31722-352-01) 100 capsule2024-09-09NoNoCurrent