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 ID: 68083-318_43fd392a-531d-4d69-917e-f19b16272d7b
• NDC: 68083-318
• Product Type: Human Prescription Drug
• Proprietary Name: Milrinone Lactate
• Generic Name: Milrinone Lactate
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-07-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077190
• Labeler Name: Gland Pharma Limited
• Substance Name: MILRINONE LACTATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68083-318-10

10 SYRINGE in 1 CARTON (68083-318-10) > 5 mL in 1 SYRINGE (68083-318-01)

• Marketing Start Date: 2017-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-318-01 [68083031801]

Milrinone Lactate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA077190
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28

NDC 68083-318-10 [68083031810]

Milrinone Lactate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA077190
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MILRINONE LACTATE	1 mg/mL

OpenFDA Data

• SPL SET ID: fa8c2d27-bb10-4966-bd8e-193fd921ea17
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • 9K8XR81MO8
• RxNorm Concept Unique ID - RxCUI:
  • 1939322

Pharmacological Class

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

NDC Crossover Matching brand name "Milrinone Lactate" or generic name "Milrinone Lactate"

NDC	Brand Name	Generic Name
0143-9326	Milrinone Lactate	Milrinone Lactate
0143-9373	Milrinone Lactate	Milrinone Lactate
0143-9374	Milrinone Lactate	Milrinone Lactate
0143-9708	Milrinone Lactate	Milrinone Lactate
0143-9709	Milrinone Lactate	Milrinone Lactate
0143-9710	Milrinone Lactate	Milrinone Lactate
0409-0212	MILRINONE LACTATE	MILRINONE LACTATE
0409-2776	Milrinone Lactate	Milrinone Lactate
0641-6065	Milrinone Lactate	Milrinone Lactate
0641-6067	Milrinone Lactate	Milrinone Lactate
55150-287	Milrinone Lactate	Milrinone Lactate
55150-288	Milrinone Lactate	Milrinone Lactate
63323-617	Milrinone Lactate	MILRINONE LACTATE
65145-120	Milrinone Lactate	Milrinone Lactate
65145-121	Milrinone Lactate	Milrinone Lactate
65145-122	Milrinone Lactate	Milrinone Lactate
68083-318	Milrinone Lactate	Milrinone Lactate
71288-200	Milrinone Lactate	Milrinone Lactate
0338-6010	Milrinone Lactate in Dextrose	MILRINONE LACTATE
0338-6011	Milrinone Lactate in Dextrose	MILRINONE LACTATE
25021-313	Milrinone Lactate in Dextrose	Milrinone Lactate
68083-410	Milrinone Lactate in Dextrose	Milrinone Lactate
68083-411	Milrinone Lactate in Dextrose	Milrinone Lactate