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United States · US · US:69238-1662_eef82f5e-a712-475a-9206-91891d462bee
Scopolamine
In shortageOrange BookUNIISPLATC S01FA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeS01FA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11692381662210 PATCH in 1 CARTON (69238-1662-2) / 3 d in 1 PATCH
- ndc11692381662424 PATCH in 1 CARTON (69238-1662-4) / 3 d in 1 PATCH
- ndc1169238166294 PATCH in 1 CARTON (69238-1662-9) / 3 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
DL48G20X8X
SCOPOLAMINE
RxCUI 9601
Orange Book
A218384
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": "69238-1662_eef82f5e-a712-475a-9206-91891d462bee",
"productndc": "69238-1662",
"dosage_form": "PATCH, EXTENDED RELEASE",
"orange_book": {
"appl_no": "218384",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/72HR",
"product_no": "001",
"approval_date": "Jun 9, 2025"
}
],
"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/3d",
"application_number": "ANDA218384",
"marketing_category": "ANDA",
"nonproprietary_name": "Scopolamine",
"start_marketing_date": "20250611",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01FA02.
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