Milrinone Lactate
MILRINONE LACTATE INJECTION, USP MILRINONE LACTATE IN 5% DEXTROSE INJECTION
Approved
Approval ID
88f78780-399f-4780-be19-205739db1682
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 3
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 Code0143-9708
Application NumberANDA077966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9710
Application NumberANDA077966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (5)
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
LACTIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9709
Application NumberANDA077966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DEXTROSEInactive
Quantity: 47 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
LACTIC ACIDInactive
Quantity: 1 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT