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United States · US · US:0409-1401_67995dbc-0e79-4b3b-a6f8-eaeb5048ff3d

Regadenoson

Orange BookUNIISPLATC C01EB21

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

Identification

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

Packs · 1

  • ndc11
    0409140101
    10 CARTON in 1 PACKAGE (0409-1401-01) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-1401-05)

Annotations

UNII (FDA Substance ID)
7AXV542LZ4
REGADENOSON ANHYDROUS
RxCUI 1546015
Orange Book
A214349
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AXV542LZ4",
    "rxcui": "1546015",
    "inchikey": "LZPZPHGJDAGEJZ-AKAIJSEGSA-N",
    "display_name": "REGADENOSON ANHYDROUS",
    "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": "0409-1401_67995dbc-0e79-4b3b-a6f8-eaeb5048ff3d",
  "productndc": "0409-1401",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214349",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/5ML (0.08MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 31, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REGADENOSON ANHYDROUS",
  "proprietary_name": "Regadenoson",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214349",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Regadenoson",
  "start_marketing_date": "20230301",
  "active_numerator_strength": ".08"
}

Related drugs

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