milrinone lactate

Generic: milrinone lactate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milrinone lactate
Generic Name milrinone lactate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

milrinone lactate 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-617
Product ID 63323-617_7ada1876-c47a-4e3e-bd48-a6a1f486b517
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075936
Listing Expiration 2026-12-31
Marketing Start 2002-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323617
Hyphenated Format 63323-617

Supplemental Identifiers

RxCUI
1791854 1791859 1791861
UPC
0363323617509 0363323617028 0363323617011
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 ANDA075936 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01)
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02)
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

63323-617-10 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01) 63323-617-20 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02) 63323-617-50 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 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": "7ada1876-c47a-4e3e-bd48-a6a1f486b517", "openfda": {"upc": ["0363323617509", "0363323617028", "0363323617011"], "unii": ["9K8XR81MO8"], "rxcui": ["1791854", "1791859", "1791861"], "spl_set_id": ["ac43ba6b-635d-4129-8eea-96f3f5a4785e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01)", "package_ndc": "63323-617-10", "marketing_start_date": "20020801"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02)", "package_ndc": "63323-617-20", "marketing_start_date": "20020801"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-617-50", "marketing_start_date": "20020801"}], "brand_name": "Milrinone Lactate", "product_id": "63323-617_7ada1876-c47a-4e3e-bd48-a6a1f486b517", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "63323-617", "generic_name": "MILRINONE LACTATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Milrinone Lactate", "active_ingredients": [{"name": "MILRINONE LACTATE", "strength": "1 mg/mL"}], "application_number": "ANDA075936", "marketing_category": "ANDA", "marketing_start_date": "20020801", "listing_expiration_date": "20261231"}