FDA.reportPublic FDA data

XELSTRYM

Product NDC
68968-0220
11-digit product format
689680220
Labeler code
68968
Product ID
68968-0220_11163145-d173-4320-aac9-92069f0cbf4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROAMPHETAMINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Noven Therapeutics, LLC
Application
NDA215401
Marketing category
NDA
Marketing start
2023-05-15
Substance
DEXTROAMPHETAMINE
Active strength
18 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
XELSTRYM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE18 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTZ47U051FI
Rxcui2624701, 2624708, 2624712, 2624715, 2624726, 2624729, 2624732, 2624735

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-0220-1XELSTRYM1 in 1 POUCHPATCH, EXTENDED RELEASE117
68968-0220-3XELSTRYM30 in 1 CARTONPATCH, EXTENDED RELEASE3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-0220-1EA - Each68968-02207b612f9f-8871-4627-b308-395bcc7685ac12022-11-07
68968-0220-3EA - Each68968-0220da19ceec-a45b-4ce1-a269-585803b83ee512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-0220XELSTRYM (DEXTROAMPHETAMINE) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]14Current NDC, Legacy NDC, 2 package rows20241222_0862f02a-72a8-41cc-8845-57cf4974bb6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2624701dextroamphetamine 13.5 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624712dextroamphetamine 18 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624726dextroamphetamine 4.5 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624732dextroamphetamine 9 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624708Xelstrym 13.5 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624715Xelstrym 18 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624729Xelstrym 4.5 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624735Xelstrym 9 MG in 9 HR Transdermal SystemPSN0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247299 HR dextroamphetamine 0.5 MG/HR Transdermal System [Xelstrym]SBD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247359 HR dextroamphetamine 1 MG/HR Transdermal System [Xelstrym]SBD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247089 HR dextroamphetamine 1.5 MG/HR Transdermal System [Xelstrym]SBD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247159 HR dextroamphetamine 2 MG/HR Transdermal System [Xelstrym]SBD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247269 HR dextroamphetamine 0.5 MG/HR Transdermal SystemSCD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247329 HR dextroamphetamine 1 MG/HR Transdermal SystemSCD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247019 HR dextroamphetamine 1.5 MG/HR Transdermal SystemSCD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247129 HR dextroamphetamine 2 MG/HR Transdermal SystemSCD0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247299 HR Xelstrym 0.5 MG/HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247359 HR Xelstrym 1 MG/HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247089 HR Xelstrym 1.5 MG/HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
26247159 HR Xelstrym 2 MG/HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624701dextroamphetamine 13.5 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624712dextroamphetamine 18 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624726dextroamphetamine 4.5 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624732dextroamphetamine 9 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624708Xelstrym 13.5 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624715Xelstrym 18 MG in per HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624729Xelstrym 4.5 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17
2624735Xelstrym 9 MG per 9 HR Transdermal SystemSY0862f02a-72a8-41cc-8845-57cf4974bb6f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68968-0220-1689680220011 in 1 POUCHHistorical
68968-0220-36896802200330 POUCH in 1 CARTON (68968-0220-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0220-1) 30 pouch2023-05-150000-00-00NoNoCurrent