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United States · US · US:71288-201_347eb6ed-dadc-4127-be90-24f65150fbff
Regadenoson
Orange BookUNIISPLATC C01EB21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC01EB21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288201851 SYRINGE, PLASTIC in 1 CARTON (71288-201-85) / 5 mL in 1 SYRINGE, PLASTIC
Annotations
UNII (FDA Substance ID)
2XLN4Y044H
REGADENOSON
RxCUI 640062
Orange Book
A212806
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": "71288-201_347eb6ed-dadc-4127-be90-24f65150fbff",
"productndc": "71288-201",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212806",
"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",
"proprietary_name": "Regadenoson",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212806",
"marketing_category": "ANDA",
"nonproprietary_name": "Regadenoson",
"start_marketing_date": "20220411",
"active_numerator_strength": ".08"
}Related drugs
Other records sharing ATC code C01EB21.
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