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United States · US · US:45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce
Scopolamine Transdermal System
In shortageOrange BookUNIISPLATC S01FA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeS01FA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11458025804610 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
- ndc11458025806224 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
- ndc1145802580844 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
Annotations
UNII (FDA Substance ID)
DL48G20X8X
SCOPOLAMINE
RxCUI 9601
Orange Book
A078830
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Scopolamine Transdermal System
Raw payload (JSON)
{
"unii": {
"unii": "DL48G20X8X",
"rxcui": "9601",
"inchikey": "STECJAGHUSJQJN-FWXGHANASA-N",
"display_name": "SCOPOLAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"51289d8b-f7e3-a3e0-e063-6294a90add43": {
"match": "brand_token",
"title": "SCOPOLAMINE PATCH, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-05-11"
}
},
"productid": "45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce",
"productndc": "45802-580",
"dosage_form": "PATCH, EXTENDED RELEASE",
"orange_book": {
"appl_no": "078830",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/72HR",
"product_no": "001",
"approval_date": "Jan 30, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SCOPOLAMINE",
"shortage_reason": "Scopolamine Transdermal System",
"shortage_status": "current",
"proprietary_name": "Scopolamine Transdermal System",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078830",
"marketing_category": "ANDA",
"nonproprietary_name": "scopolamine transdermal system",
"start_marketing_date": "20170613",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01FA02.
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