Milrinone Lactate
Milrinone Lactate in 5% Dextrose Injection Rx only
Approved
Approval ID
4e489fab-75bc-4514-9bf2-85b8ed08a1b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Milrinone Lactate in 5% Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-288
Application NumberANDA209666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate in 5% Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 17, 2023
FDA Product Classification
INGREDIENTS (5)
MILRINONE LACTATEActive
Quantity: 0.2 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.282 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 54.3 mg in 1 mL
Code: LX22YL083G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Milrinone Lactate in 5% Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-287
Application NumberANDA209666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate in 5% Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 17, 2023
FDA Product Classification
INGREDIENTS (5)
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.282 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
MILRINONE LACTATEActive
Quantity: 0.2 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 54.3 mg in 1 mL
Code: LX22YL083G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT