Neupro

Orange BookUNIISPLATC N04BC09

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

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC codeN04BC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5047480503
30 POUCH in 1 CARTON (50474-805-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
ndc11
5047480517
7 POUCH in 1 CARTON (50474-805-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

87T4T8BO2E

ROTIGOTINE

RxCUI 616739

Orange Book

N021829

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "87T4T8BO2E",
    "rxcui": "616739",
    "inchikey": "KFQYTPMOWPVWEJ-INIZCTEOSA-N",
    "display_name": "ROTIGOTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "939e28c5-f3a9-42c0-9a2d-8d471d82a6e0": {
      "match": "brand_token",
      "title": "NEUPRO (ROTIGOTINE) PATCH, EXTENDED RELEASE NEUPRO (ROTIGOTINE) KIT [UCB, INC.]",
      "spl_version": "20",
      "published_date": "2025-06-26"
    }
  },
  "productid": "50474-805_385797e6-a44d-f4af-e063-6294a90a178a",
  "productndc": "50474-805",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021829",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/24HR",
        "product_no": "001",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG/24HR",
        "product_no": "002",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG/24HR",
        "product_no": "003",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/24HR",
        "product_no": "004",
        "approval_date": "Apr 2, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3MG/24HR",
        "product_no": "005",
        "approval_date": "Apr 2, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG/24HR",
        "product_no": "006",
        "approval_date": "Apr 2, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROTIGOTINE",
  "proprietary_name": "Neupro",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA021829",
  "marketing_category": "NDA",
  "nonproprietary_name": "rotigotine",
  "start_marketing_date": "20120402",
  "active_numerator_strength": "6"
}

Related drugs

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