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United States · US · US:0078-0502_9b5555ca-d9a2-4f50-8037-abbf702d0a27

Exelon

Orange BookUNIISPLATC N06DA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeN06DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078050215
    30 PATCH in 1 CARTON (0078-0502-15) / 24 h in 1 PATCH (0078-0502-61)

Annotations

UNII (FDA Substance ID)
PKI06M3IW0
RIVASTIGMINE
RxCUI 183379
Orange Book
N022083
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PKI06M3IW0",
    "rxcui": "183379",
    "inchikey": "XSVMFMHYUFZWBK-NSHDSACASA-N",
    "display_name": "RIVASTIGMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0": {
      "match": "brand_token",
      "title": "EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "30",
      "published_date": "2025-10-06"
    }
  },
  "productid": "0078-0502_9b5555ca-d9a2-4f50-8037-abbf702d0a27",
  "productndc": "0078-0502",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022083",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4.6MG/24HR",
        "product_no": "001",
        "approval_date": "Jul 6, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "9.5MG/24HR",
        "product_no": "002",
        "approval_date": "Jul 6, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "13.3MG/24HR",
        "product_no": "005",
        "approval_date": "Aug 31, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIVASTIGMINE",
  "proprietary_name": "Exelon",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA022083",
  "marketing_category": "NDA",
  "nonproprietary_name": "rivastigmine",
  "start_marketing_date": "20070706",
  "active_numerator_strength": "9.5"
}

Related drugs

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