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Milrinone Lactate

Milrinone Lactate Injection FOR INTRAVENOUS USE Rx only

Approved
Approval ID

26b11116-95f5-488f-a9c0-3b07d4db6678

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 3, 2011

Manufacturers
FDA

West-ward Pharmaceutical Corp.

DUNS: 946499746

Products 2

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

Milrinone Lactate

PRODUCT DETAILS

NDC Product Code0641-6065
Application NumberANDA075530
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2011
Generic NameMilrinone Lactate

INGREDIENTS (5)

MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Milrinone Lactate

PRODUCT DETAILS

NDC Product Code0641-6067
Application NumberANDA075530
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2011
Generic NameMilrinone Lactate

INGREDIENTS (5)

MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT

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Milrinone Lactate - FDA Drug Approval Details