milrinone lactate

Generic: milrinone lactate

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milrinone lactate
Generic Name milrinone lactate
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

milrinone lactate 1 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-200
Product ID 71288-200_9fb02532-b43c-40c3-adf1-f5071a415e05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211671
Listing Expiration 2026-12-31
Marketing Start 2020-03-24

Pharmacologic Class

Classes
phosphodiesterase 3 inhibitor [epc] phosphodiesterase 3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288200
Hyphenated Format 71288-200

Supplemental Identifiers

RxCUI
1791854 1791859 1791861
UNII
9K8XR81MO8

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name milrinone lactate (source: ndc)
Generic Name milrinone lactate (source: ndc)
Application Number ANDA211671 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-200-10)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-200-20)
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

71288-200-11 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-200-10) 71288-200-21 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-200-20) 71288-200-50 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

milrinone lactate (1 mg/mL)

Linked Drug Pages (1)

Milrinone Lactate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9fb02532-b43c-40c3-adf1-f5071a415e05", "openfda": {"unii": ["9K8XR81MO8"], "rxcui": ["1791854", "1791859", "1791861"], "spl_set_id": ["6c6b69f9-e229-4a93-a108-9eafdab614f0"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-200-10)", "package_ndc": "71288-200-11", "marketing_start_date": "20200324"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-21)  / 20 mL in 1 VIAL, SINGLE-DOSE (71288-200-20)", "package_ndc": "71288-200-21", "marketing_start_date": "20200324"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-200-50", "marketing_start_date": "20200324"}], "brand_name": "Milrinone Lactate", "product_id": "71288-200_9fb02532-b43c-40c3-adf1-f5071a415e05", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "71288-200", "generic_name": "Milrinone Lactate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Milrinone Lactate", "active_ingredients": [{"name": "MILRINONE LACTATE", "strength": "1 mg/mL"}], "application_number": "ANDA211671", "marketing_category": "ANDA", "marketing_start_date": "20200324", "listing_expiration_date": "20261231"}