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United States · US · US:27505-006_52f6e08a-6bd3-3b01-e063-6394a90ae8a6

ONAPGO

Orange BookUNIISPLATC N04BC07

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

Identification

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

Packs · 1

  • ndc11
    2750500605
    5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01)

Annotations

UNII (FDA Substance ID)
F39049Y068
APOMORPHINE HYDROCHLORIDE
RxCUI 71225
Orange Book
N214056
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": {
    "f3552b6e-5ae7-4993-aa1a-e399c4a7080a": {
      "match": "brand_token",
      "title": "ONAPGO (APOMORPHINE HYDROCHLORIDE) INJECTION, SOLUTION [MDD US OPERATIONS, LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC]",
      "spl_version": "17",
      "published_date": "2026-06-01"
    }
  },
  "productid": "27505-006_52f6e08a-6bd3-3b01-e063-6394a90ae8a6",
  "productndc": "27505-006",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214056",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "98MG/20ML (4.9MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 3, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APOMORPHINE HYDROCHLORIDE",
  "proprietary_name": "ONAPGO",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA214056",
  "marketing_category": "NDA",
  "nonproprietary_name": "Apomorphine hydrochloride",
  "start_marketing_date": "20250204",
  "active_numerator_strength": "4.9"
}

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