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United States · US · US:68071-3994_51288b87-a0ea-5505-e063-6394a90a3736
Scopolamine
In shortageOrange BookUNIISPLATC S01FA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01FA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168071399444 POUCH in 1 CARTON (68071-3994-4) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
Annotations
UNII (FDA Substance ID)
DL48G20X8X
SCOPOLAMINE
RxCUI 9601
Orange Book
A212342
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": "68071-3994_51288b87-a0ea-5505-e063-6394a90a3736",
"productndc": "68071-3994",
"dosage_form": "PATCH, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212342",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "1MG/72HR",
"product_no": "001",
"approval_date": "Nov 24, 2020"
}
],
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212342",
"marketing_category": "ANDA",
"nonproprietary_name": "Scopolamine",
"start_marketing_date": "20201124",
"active_numerator_strength": "1.5"
}Related drugs
Other records sharing ATC code S01FA02.
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