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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6065
Application NumberANDA075530
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2011
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6067
Application NumberANDA075530
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2011
FDA Product Classification
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