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United States · US · US:0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0
scopolamine
In shortageOrange BookUNIISPLATC S01FA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeS01FA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1105912258044 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
- ndc11059122582324 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
- ndc11059122587910 POUCH in 1 CARTON (0591-2258-79) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
DL48G20X8X
SCOPOLAMINE
RxCUI 9601
Orange Book
A208769
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": "0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0",
"productndc": "0591-2258",
"dosage_form": "SYSTEM",
"orange_book": {
"appl_no": "208769",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG/72HR",
"product_no": "001",
"approval_date": "Jan 10, 2022"
}
],
"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": "ANDA208769",
"marketing_category": "ANDA",
"nonproprietary_name": "scopolamine",
"start_marketing_date": "20220512",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01FA02.
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