Rivastigmine

Orange BookUNIISPLATC N06DA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378907093
30 POUCH in 1 CARTON (0378-9070-93) / 1 PATCH in 1 POUCH (0378-9070-16) / 24 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

PKI06M3IW0

RIVASTIGMINE

RxCUI 183379

Orange Book

A205622

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": {
    "52781229-ee82-43f9-a113-4419a611978d": {
      "match": "brand_token",
      "title": "RIVASTIGMINE TARTRATE CAPSULE [AMERICAN HEALTH PACKAGING]",
      "spl_version": "2",
      "published_date": "2025-11-21"
    }
  },
  "productid": "0378-9070_c1d8c8a9-87e9-4ca1-ba70-4a7467205fd4",
  "productndc": "0378-9070",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "205622",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4.6MG/24HR",
        "product_no": "001",
        "approval_date": "Jun 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "9.5MG/24HR",
        "product_no": "002",
        "approval_date": "Jun 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "13.3MG/24HR",
        "product_no": "003",
        "approval_date": "Jun 20, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIVASTIGMINE",
  "proprietary_name": "Rivastigmine",
  "active_ingred_unit": "mg/24h",
  "application_number": "ANDA205622",
  "marketing_category": "ANDA",
  "nonproprietary_name": "rivastigmine",
  "start_marketing_date": "20180620",
  "active_numerator_strength": "4.6"
}

Related drugs

Other records sharing ATC code N06DA03.

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