Milrinone Lactate
Milrinone Lactate Injection, USP Rx Only
Approved
Approval ID
ce43e850-4e80-4c5b-8811-9cb65824768c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2022
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-808
Application NumberANDA214380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 24, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-809
Application NumberANDA214380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 24, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-807
Application NumberANDA214380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 24, 2022
FDA Product Classification
INGREDIENTS (5)
MILRINONE LACTATEActive
Quantity: 1 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT