FDA.reportPublic FDA data

NDC 68968-0215-03 - XELSTRYM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68968-0215
Requested NDC
68968-0215-03
Package NDCs from labels
68968-0215-1, 68968-0215-3, 68968-0215-03
Manufacturer
Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XELSTRYM - Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.2025-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-0215-1XELSTRYM1 in 1 POUCHPATCH, EXTENDED RELEASE117
68968-0215-3XELSTRYM30 in 1 CARTONPATCH, EXTENDED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-0215XELSTRYM (DEXTROAMPHETAMINE) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]14Current NDC, Legacy NDC, 2 package rows20241222_0862f02a-72a8-41cc-8845-57cf4974bb6f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-0215-1EA - Each68968-0215c2716579-b65b-4b52-8ed5-296ef1a09a8112022-11-07
68968-0215-3EA - Each68968-021572a60c70-bf63-4401-9e31-03b5bb7c062612022-11-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 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 number: NDA215401
ndc (package): 68968-0215-1
ndc (package): 68968-0210-1
ndc (package): 68968-0205-1
ndc (package): 68968-0220-1
ndc (package): 68968-0220-3
ndc (package): 68968-0215-3
ndc (package): 68968-0205-3
ndc (package): 68968-0210-3
ndc (product): 68968-0215
ndc (product): 68968-0220
ndc (product): 68968-0210
ndc (product): 68968-0205
ndc11 (package): 68968021503
rxcui: 2624732
rxcui: 2624735
rxcui: 2624729
rxcui: 2624715
rxcui: 2624701
rxcui: 2624712
rxcui: 2624708
rxcui: 2624726
spl id: 11163145-d173-4320-aac9-92069f0cbf4a
spl set id: 0862f02a-72a8-41cc-8845-57cf4974bb6f
unii: TZ47U051FI

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.