Neupro

Orange BookSPL

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

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5047480811
2 BOX in 1 KIT (50474-808-11) / 1 KIT in 1 BOX * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH

Annotations

Orange Book

N021829

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "50474-808_385797e6-a44d-f4af-e063-6294a90a178a",
  "productndc": "50474-808",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Neupro",
  "active_ingred_unit": null,
  "application_number": "NDA021829",
  "marketing_category": "NDA",
  "nonproprietary_name": "rotigotine",
  "start_marketing_date": "20120402",
  "active_numerator_strength": null
}

Access this data programmatically

Query Neupro 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.

Get a free API key Read the API docs