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United States · US · US:43598-616_4b43c865-fcdb-4e57-30a4-871e37e0e593

Regadenoson

Orange BookUNIISPLATC C01EB21

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeC01EB21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359861611
    5 mL in 1 CARTON (43598-616-11)

Annotations

UNII (FDA Substance ID)
7AXV542LZ4
REGADENOSON ANHYDROUS
RxCUI 1546015
Orange Book
A213210
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": "43598-616_4b43c865-fcdb-4e57-30a4-871e37e0e593",
  "productndc": "43598-616",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "213210",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/5ML (0.08MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 11, 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": "ANDA213210",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Regadenoson",
  "start_marketing_date": "20230423",
  "active_numerator_strength": ".08"
}

Related drugs

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