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United States · US · US:85742-012_10a89235-f50b-4c94-a52f-c05470e20523

Regadenoson

Orange BookUNIISPLATC C01EB21

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

Identification

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

Packs · 1

  • ndc11
    8574201209
    1 SYRINGE in 1 CARTON (85742-012-09) / 5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
2XLN4Y044H
REGADENOSON
RxCUI 640062
Orange Book
A218054
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": "85742-012_10a89235-f50b-4c94-a52f-c05470e20523",
  "productndc": "85742-012",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218054",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/5ML (0.08MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REGADENOSON",
  "proprietary_name": "Regadenoson",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218054",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Regadenoson",
  "start_marketing_date": "20240822",
  "active_numerator_strength": ".08"
}

Related drugs

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