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United States · US · US:36000-364_9f2129bf-2527-42da-b07a-f20cac3246de

regadenoson

Orange BookUNIISPLATC C01EB21

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeC01EB21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3600036401
    1 SYRINGE, PLASTIC in 1 CARTON (36000-364-01) / 5 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)
2XLN4Y044H
REGADENOSON
RxCUI 640062
Orange Book
A217455
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2XLN4Y044H",
    "rxcui": "640062",
    "inchikey": "CDQVVPUXSPZONN-WPPLYIOHSA-N",
    "display_name": "REGADENOSON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5095ab40-8503-46db-9b08-6a36f05fb5d9": {
      "match": "brand_token",
      "title": "REGADENOSON INJECTION, SOLUTION [INDIES PHARMA JAMAICA LIMITED]",
      "spl_version": "2",
      "published_date": "2025-12-29"
    }
  },
  "productid": "36000-364_9f2129bf-2527-42da-b07a-f20cac3246de",
  "productndc": "36000-364",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217455",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/5ML (0.08MG/ML)",
        "product_no": "001",
        "approval_date": "May 23, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REGADENOSON",
  "proprietary_name": "regadenoson",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217455",
  "marketing_category": "ANDA",
  "nonproprietary_name": "regadenoson",
  "start_marketing_date": "20230523",
  "active_numerator_strength": ".08"
}

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