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United States · US · US:0378-6470_79930eea-4bac-4412-871f-5cd0933bef05
Scopolamine
In shortageOrange BookUNIISPLATC S01FA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01FA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11037864704424 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
- ndc11037864709710 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
- ndc1103786470994 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
DL48G20X8X
SCOPOLAMINE
RxCUI 9601
Orange Book
A203753
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": "0378-6470_79930eea-4bac-4412-871f-5cd0933bef05",
"productndc": "0378-6470",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "203753",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/72HR",
"product_no": "001",
"approval_date": "Jun 19, 2019"
}
],
"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": "ANDA203753",
"marketing_category": "ANDA",
"nonproprietary_name": "scopolamine",
"start_marketing_date": "20190619",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01FA02.
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