Back to search
🇺🇸

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

  • ndc11
    0591225804
    4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • ndc11
    0591225823
    24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • ndc11
    0591225879
    10 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.

Access this data programmatically

Query scopolamine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.