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United States · US · US:68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f
Regadenoson
Orange BookUNIISPLATC C01EB21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeC01EB21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680831751010 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01)
Annotations
UNII (FDA Substance ID)
2XLN4Y044H
REGADENOSON
RxCUI 640062
Orange Book
A207320
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": "68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f",
"productndc": "68083-175",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207320",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/5ML (0.08MG/ML)",
"product_no": "001",
"approval_date": "Jul 12, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "REGADENOSON",
"proprietary_name": "Regadenoson",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207320",
"marketing_category": "ANDA",
"nonproprietary_name": "Regadenoson",
"start_marketing_date": "20220712",
"active_numerator_strength": ".08"
}Related drugs
Other records sharing ATC code C01EB21.
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