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Active ingredient

Regadenoson

16 finished FDA listings contain Regadenoson as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
REGADENOSON, REGADENOSON ANHYDROUS
Dosage forms
Injection, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
15
Strengths listed
.08 mg/ml
Brand names in FDA listings
Lexiscan

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 640062

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022161ASTELLAS2008-04-102
ANDA 207604APOTEX2022-04-112
ANDA 212806MEITHEAL2022-04-111
ANDA 213210DR REDDYS2022-04-111
ANDA 213236ACCORD HLTHCARE2022-04-111
ANDA 214252IMS LTD2022-05-231
ANDA 207320GLAND2022-07-121
ANDA 214349HOSPIRA2022-08-311
ANDA 216437EUGIA PHARMA2022-10-261
ANDA 215827HIKMA2023-02-021
ANDA 217455BAXTER HLTHCARE CORP2023-05-231
ANDA 218054INDIES PHARMA2024-08-223

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.