Angiomax RTU

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 079211845

Effective Date

November 5, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Bivalirudin(250 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70511-141

Application Number

NDA211215

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

November 5, 2019

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 40 mg in 1 1

Code: TN9BEX005GClass: ACTIBQuantity: 250 mg in 1 1

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACTQuantity: 5 g in 1 1

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT