Milrinone Lactate in Dextrose
Milrinone Lactate in 5% Dextrose Injection (For Intravenous Use) Rx only
Approved
Approval ID
838da14b-c070-4c09-b088-99e7c64d9964
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2021
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-410
Application NumberANDA213585
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (5)
MILRINONE LACTATEActive
Quantity: 0.2 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
LACTIC ACIDInactive
Quantity: 0.282 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 54.3 mg in 1 mL
Code: LX22YL083G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-411
Application NumberANDA213585
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (5)
LACTIC ACIDInactive
Quantity: 0.282 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 54.3 mg in 1 mL
Code: LX22YL083G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MILRINONE LACTATEActive
Quantity: 0.2 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM