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United States · US · US:68968-0220_11163145-d173-4320-aac9-92069f0cbf4a
XELSTRYM
Orange BookUNIISPLATC N06BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNoven Therapeutics, LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11689680220330 POUCH in 1 CARTON (68968-0220-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0220-1)
Annotations
UNII (FDA Substance ID)
TZ47U051FI
DEXTROAMPHETAMINE
RxCUI 3288
Orange Book
N215401
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TZ47U051FI",
"rxcui": "3288",
"inchikey": "KWTSXDURSIMDCE-QMMMGPOBSA-N",
"display_name": "DEXTROAMPHETAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"0862f02a-72a8-41cc-8845-57cf4974bb6f": {
"match": "brand_token",
"title": "XELSTRYM (DEXTROAMPHETAMINE) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]",
"spl_version": "17",
"published_date": "2025-12-25"
}
},
"productid": "68968-0220_11163145-d173-4320-aac9-92069f0cbf4a",
"productndc": "68968-0220",
"dosage_form": "PATCH, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215401",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "4.5MG/9HR",
"product_no": "001",
"approval_date": "Mar 22, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG/9HR",
"product_no": "002",
"approval_date": "Mar 22, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "13.5MG/9HR",
"product_no": "003",
"approval_date": "Mar 22, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "18MG/9HR",
"product_no": "004",
"approval_date": "Mar 22, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROAMPHETAMINE",
"proprietary_name": "XELSTRYM",
"active_ingred_unit": "mg/1",
"application_number": "NDA215401",
"marketing_category": "NDA",
"nonproprietary_name": "DEXTROAMPHETAMINE",
"start_marketing_date": "20230515",
"active_numerator_strength": "18"
}Related drugs
Other records sharing ATC code N06BA02.
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