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United States · US · US:27505-004_41c194a6-daa8-f307-e063-6394a90ade0d

APOKYN

Orange BookUNIISPLATC N04BC07

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

Identification

ManufacturerMDD US Operations, LLC
CountryUS (United States)
ATC codeN04BC07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2750500405
    5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01)

Annotations

UNII (FDA Substance ID)
F39049Y068
APOMORPHINE HYDROCHLORIDE
RxCUI 71225
Orange Book
N021264
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "F39049Y068",
    "rxcui": "71225",
    "inchikey": "CXWQXGNFZLHLHQ-DPFCLETOSA-N",
    "display_name": "APOMORPHINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "3235535d-9ef9-4657-8b2a-176a807d091c": {
      "match": "brand_token",
      "title": "APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [MDD US OPERATIONS, LLC]",
      "spl_version": "21",
      "published_date": "2024-10-14"
    }
  },
  "productid": "27505-004_41c194a6-daa8-f307-e063-6394a90ade0d",
  "productndc": "27505-004",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021264",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 20, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "30MG/3ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 20, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APOMORPHINE HYDROCHLORIDE",
  "proprietary_name": "APOKYN",
  "active_ingred_unit": "mg/3mL",
  "application_number": "NDA021264",
  "marketing_category": "NDA",
  "nonproprietary_name": "APOMORPHINE HYDROCHLORIDE",
  "start_marketing_date": "20040702",
  "active_numerator_strength": "30"
}

Related drugs

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