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XELSTRYM

These highlights do not include all the information needed to use XELSTRYM safely and effectively. See full prescribing information for XELSTRYM. XELSTRYM (dextroamphetamine) transdermal system, CII Initial U.S. Approval: 1975

Approved
Approval ID

0862f02a-72a8-41cc-8845-57cf4974bb6f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2023

Manufacturers
FDA

Noven Therapeutics, LLC

DUNS: 166888268

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DEXTROAMPHETAMINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68968-0220
Application NumberNDA215401
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROAMPHETAMINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 21, 2023
FDA Product Classification

INGREDIENTS (1)

DEXTROAMPHETAMINEActive
Quantity: 18 mg in 1 1
Code: TZ47U051FI
Classification: ACTIB

DEXTROAMPHETAMINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68968-0215
Application NumberNDA215401
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROAMPHETAMINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 21, 2023
FDA Product Classification

INGREDIENTS (1)

DEXTROAMPHETAMINEActive
Quantity: 13.5 mg in 1 1
Code: TZ47U051FI
Classification: ACTIB

DEXTROAMPHETAMINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68968-0205
Application NumberNDA215401
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROAMPHETAMINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 21, 2023
FDA Product Classification

INGREDIENTS (1)

DEXTROAMPHETAMINEActive
Quantity: 4.5 mg in 1 1
Code: TZ47U051FI
Classification: ACTIB

DEXTROAMPHETAMINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68968-0210
Application NumberNDA215401
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROAMPHETAMINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 21, 2023
FDA Product Classification

INGREDIENTS (1)

DEXTROAMPHETAMINEActive
Quantity: 9 mg in 1 1
Code: TZ47U051FI
Classification: ACTIB

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