NDC 68083-175

Regadenoson

Regadenoson

Regadenoson is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Regadenoson.

Product ID68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f
NDC68083-175
Product TypeHuman Prescription Drug
Proprietary NameRegadenoson
Generic NameRegadenoson
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-07-12
Marketing CategoryANDA /
Application NumberANDA207320
Labeler NameGland Pharma Limited
Substance NameREGADENOSON
Active Ingredient Strength0 mg/mL
Pharm ClassesAdenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-175-10

10 VIAL in 1 CARTON (68083-175-10) > 5 mL in 1 VIAL (68083-175-01)
Marketing Start Date2022-07-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Regadenoson" or generic name "Regadenoson"

NDCBrand NameGeneric Name
55150-443regadenosonregadenoson
68083-175RegadenosonRegadenoson
71288-201RegadenosonRegadenoson
0469-6501LEXISCANregadenoson

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