NDC 68083-318

Milrinone Lactate

Milrinone Lactate

Milrinone Lactate is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Milrinone Lactate.

Product ID68083-318_43fd392a-531d-4d69-917e-f19b16272d7b
NDC68083-318
Product TypeHuman Prescription Drug
Proprietary NameMilrinone Lactate
Generic NameMilrinone Lactate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-07-28
Marketing CategoryANDA / ANDA
Application NumberANDA077190
Labeler NameGland Pharma Limited
Substance NameMILRINONE LACTATE
Active Ingredient Strength1 mg/mL
Pharm ClassesPhosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68083-318-10

10 SYRINGE in 1 CARTON (68083-318-10) > 5 mL in 1 SYRINGE (68083-318-01)
Marketing Start Date2017-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-318-01 [68083031801]

Milrinone Lactate INJECTION
Marketing CategoryANDA
Application NumberANDA077190
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28

NDC 68083-318-10 [68083031810]

Milrinone Lactate INJECTION
Marketing CategoryANDA
Application NumberANDA077190
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MILRINONE LACTATE1 mg/mL

OpenFDA Data

SPL SET ID:fa8c2d27-bb10-4966-bd8e-193fd921ea17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1939322

    • Pharmacological Class

    • Phosphodiesterase 3 Inhibitor [EPC]
    • Phosphodiesterase 3 Inhibitors [MoA]