milrinone lactate

Generic: milrinone lactate

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

milrinone lactate 1 mg/mL

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0016
Product ID 83301-0016_2bc91e0d-da13-e864-e063-6394a90a4c0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216373
Listing Expiration 2026-12-31
Marketing Start 2023-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 833010016
Hyphenated Format 83301-0016

Supplemental Identifiers

RxCUI
1791854 1791859
UPC
0383301001618 0383301001717 0383301001724
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 ANDA216373 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83301-0016-2) / 1 mL in 1 VIAL (83301-0016-1)
source: ndc

Packages (1)

83301-0016-2 10 VIAL in 1 CARTON (83301-0016-2) / 1 mL in 1 VIAL (83301-0016-1)

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": "2bc91e0d-da13-e864-e063-6394a90a4c0e", "openfda": {"upc": ["0383301001618", "0383301001717", "0383301001724"], "unii": ["9K8XR81MO8"], "rxcui": ["1791854", "1791859"], "spl_set_id": ["07dddead-22ed-004c-e063-6294a90a76fc"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83301-0016-2)  / 1 mL in 1 VIAL (83301-0016-1)", "package_ndc": "83301-0016-2", "marketing_start_date": "20230918"}], "brand_name": "Milrinone Lactate", "product_id": "83301-0016_2bc91e0d-da13-e864-e063-6394a90a4c0e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "83301-0016", "generic_name": "Milrinone Lactate", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Milrinone Lactate", "active_ingredients": [{"name": "MILRINONE LACTATE", "strength": "1 mg/mL"}], "application_number": "ANDA216373", "marketing_category": "ANDA", "marketing_start_date": "20230918", "listing_expiration_date": "20261231"}