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United States · US · US:0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65
Regadenoson
Orange BookUNIISPLATC C01EB21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC01EB21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1106416253011 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 5 mL in 1 SYRINGE, PLASTIC
Annotations
UNII (FDA Substance ID)
7AXV542LZ4
REGADENOSON ANHYDROUS
RxCUI 1546015
Orange Book
A215827
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": "0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65",
"productndc": "0641-6253",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215827",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/5ML (0.08MG/ML)",
"product_no": "001",
"approval_date": "Feb 2, 2023"
}
],
"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": "ANDA215827",
"marketing_category": "ANDA",
"nonproprietary_name": "Regadenoson",
"start_marketing_date": "20230403",
"active_numerator_strength": ".08"
}Related drugs
Other records sharing ATC code C01EB21.
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