milrinone lactate

Generic: milrinone lactate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milrinone lactate
Generic Name milrinone lactate
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

milrinone lactate 1 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-809
Product ID 70069-809_ce43e850-4e80-4c5b-8811-9cb65824768c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214380
Listing Expiration 2026-12-31
Marketing Start 2022-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069809
Hyphenated Format 70069-809

Supplemental Identifiers

RxCUI
1791854 1791859 1791861
UPC
0370069807019 0370069809013 0370069808016
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 ANDA214380 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70069-809-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

70069-809-01 1 VIAL in 1 CARTON (70069-809-01) / 50 mL in 1 VIAL

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": "ce43e850-4e80-4c5b-8811-9cb65824768c", "openfda": {"upc": ["0370069807019", "0370069809013", "0370069808016"], "unii": ["9K8XR81MO8"], "rxcui": ["1791854", "1791859", "1791861"], "spl_set_id": ["ce43e850-4e80-4c5b-8811-9cb65824768c"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70069-809-01)  / 50 mL in 1 VIAL", "package_ndc": "70069-809-01", "marketing_start_date": "20220923"}], "brand_name": "Milrinone Lactate", "product_id": "70069-809_ce43e850-4e80-4c5b-8811-9cb65824768c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "70069-809", "generic_name": "Milrinone Lactate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Milrinone Lactate", "active_ingredients": [{"name": "MILRINONE LACTATE", "strength": "1 mg/mL"}], "application_number": "ANDA214380", "marketing_category": "ANDA", "marketing_start_date": "20220923", "listing_expiration_date": "20261231"}