Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira, Inc.
Hospira, Inc.
093132819
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Regadenoson
Product Details
NDC Product Code
0409-1401Application Number
ANDA214349Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 2, 2023RegadenosonActive
Code: 7AXV542LZ4Class: ACTIBQuantity: 0.08 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACTQuantity: 8.7 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 5.4 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 150 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT