FDA.reportPublic FDA data

XELSTRYM

Product NDC
68968-0205
11-digit product format
689680205
Labeler code
68968
Product ID
68968-0205_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
4.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215401-001XELSTRYMDEXTROAMPHETAMINE4.5MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22
N215401-002XELSTRYMDEXTROAMPHETAMINE9MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22
N215401-003XELSTRYMDEXTROAMPHETAMINE13.5MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22
N215401-004XELSTRYMDEXTROAMPHETAMINE18MG/9HRSYSTEM / TRANSDERMALRLD, RS2022-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215401-00194569932033-10-24U-3340Drug product2022-04-14
N215401-00194747222033-10-24Drug product2022-04-14
N215401-001115595012042-01-06Drug product2023-02-17
N215401-00294569932033-10-24U-3340Drug product2022-04-14
N215401-00294747222033-10-24Drug product2022-04-14
N215401-002115595012042-01-06Drug product2023-02-17
N215401-00394569932033-10-24U-3340Drug product2022-04-14
N215401-00394747222033-10-24Drug product2022-04-14
N215401-003115595012042-01-06Drug product2023-02-17
N215401-00494569932033-10-24U-3340Drug product2022-04-14
N215401-00494747222033-10-24Drug product2022-04-14
N215401-004115595012042-01-06Drug product2023-02-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N215401-001XELSTRYM4.5MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22a50c72e98297…
2026-08-01 22:54:322026-06N215401-002XELSTRYM9MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22a50c72e98297…
2026-08-01 22:54:322026-06N215401-003XELSTRYM13.5MG/9HRSYSTEM / TRANSDERMALRLD2022-03-22a50c72e98297…
2026-08-01 22:54:322026-06N215401-004XELSTRYM18MG/9HRSYSTEM / TRANSDERMALRLD, RS2022-03-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N215401-00194569932033-10-24U-3340Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-00194747222033-10-24Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-001115595012042-01-06Drug product2023-02-17a50c72e98297…
2026-08-01 22:54:322026-06N215401-00294569932033-10-24U-3340Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-00294747222033-10-24Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-002115595012042-01-06Drug product2023-02-17a50c72e98297…
2026-08-01 22:54:322026-06N215401-00394569932033-10-24U-3340Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-00394747222033-10-24Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-003115595012042-01-06Drug product2023-02-17a50c72e98297…
2026-08-01 22:54:322026-06N215401-00494569932033-10-24U-3340Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-00494747222033-10-24Drug product2022-04-14a50c72e98297…
2026-08-01 22:54:322026-06N215401-004115595012042-01-06Drug product2023-02-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XELSTRYMDEXTROAMPHETAMINENoven Therapeutics, LLC0862f02a-72a8-41cc-8845-57cf4974bb6f2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215401
application number: NDA215401
ndc (product): 68968-0205

Additional Listing Data#

Finished product
Yes
Brand name base
XELSTRYM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE4.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TZ47U051FIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2624701Internal RxNorm lookup
2624708Internal RxNorm lookup
2624712Internal RxNorm lookup
2624715Internal RxNorm lookup
2624726Internal RxNorm lookup
2624729Internal RxNorm lookup
2624732Internal RxNorm lookup
2624735Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0862f02a-72a8-41cc-8845-57cf4974bb6fAvailable on FDA.report

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
68968-0205-1XELSTRYM1 in 1 POUCHPATCH, EXTENDED RELEASE117
68968-0205-3XELSTRYM30 in 1 CARTONPATCH, EXTENDED RELEASE3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-0205-1EA - Each68968-0205f4378fef-a403-478d-ae32-453e7323e63c12022-11-07
68968-0205-3EA - Each68968-02058853d2ed-7876-4429-9fcc-e2aa5213886f12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-0205XELSTRYM (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
68968-0205-1689680205011 in 1 POUCHHistorical
68968-0205-36896802050330 POUCH in 1 CARTON (68968-0205-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1) 30 pouch2023-05-150000-00-00NoNoCurrent