Angiomax RTU
These highlights do not include all the information needed to use ANGIOMAX RTU safely and effectively. See full prescribing information for ANGIOMAX RTU.ANGIOMAX RTU (bivalirudin) injection, for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
72c5413f-882a-4784-9be6-312c0a0a2a97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2019
Manufacturers
FDA
MAIA Pharmaceuticals, Inc.
DUNS: 079211845
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bivalirudin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70511-141
Application NumberNDA211215
Product Classification
M
Marketing Category
C73594
G
Generic Name
bivalirudin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 5, 2019
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM ACETATEInactive
Quantity: 40 mg in 1 1
Code: 4550K0SC9B
Classification: IACT
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Quantity: 5 g in 1 1
Code: B697894SGQ
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT