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United States · US · US:67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16
Regadenoson
Orange BookUNIISPLATC C01EB21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeC01EB21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457994051 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
2XLN4Y044H
REGADENOSON
RxCUI 640062
Orange Book
A213856
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": "67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16",
"productndc": "67457-994",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "213856",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/5ML (0.08MG/ML)",
"product_no": "001",
"approval_date": "Apr 4, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "REGADENOSON",
"proprietary_name": "Regadenoson",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA213856",
"marketing_category": "ANDA",
"nonproprietary_name": "Regadenoson",
"start_marketing_date": "20230921",
"active_numerator_strength": ".4"
}Related drugs
Other records sharing ATC code C01EB21.
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