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United States · US · US:76329-3321_350f0b8b-7ae6-4b31-8aa3-2178f5c869d7
Regadenoson
Orange BookUNIISPLATC C01EB21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInternational Medication Systems, Limited
CountryUS (United States)
ATC codeC01EB21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176329332101 SYRINGE in 1 CARTON (76329-3321-0) / 5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
7AXV542LZ4
REGADENOSON ANHYDROUS
RxCUI 1546015
Orange Book
A214252
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": "76329-3321_350f0b8b-7ae6-4b31-8aa3-2178f5c869d7",
"productndc": "76329-3321",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214252",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/5ML (0.08MG/ML)",
"product_no": "001",
"approval_date": "May 23, 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": "ANDA214252",
"marketing_category": "ANDA",
"nonproprietary_name": "Regadenoson",
"start_marketing_date": "20230420",
"active_numerator_strength": ".08"
}Related drugs
Other records sharing ATC code C01EB21.
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