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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
- ndc11040914010110 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
Other records sharing ATC code C01EB21.
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