milrinone lactate in dextrose

Generic: milrinone lactate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milrinone lactate in dextrose
Generic Name milrinone lactate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

milrinone lactate .2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-411
Product ID 68083-411_4522009c-38db-44c1-8d16-c44f674a9920
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213585
Listing Expiration 2026-12-31
Marketing Start 2020-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083411
Hyphenated Format 68083-411

Supplemental Identifiers

RxCUI
1791840 1791842
UPC
0368083410018 0368083411015
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 in dextrose (source: ndc)
Generic Name milrinone lactate (source: ndc)
Application Number ANDA213585 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (68083-411-10) / 1 BAG in 1 CARTON (68083-411-01) / 200 mL in 1 BAG
source: ndc

Packages (1)

68083-411-10 10 CARTON in 1 CARTON (68083-411-10) / 1 BAG in 1 CARTON (68083-411-01) / 200 mL in 1 BAG

Ingredients (1)

milrinone lactate (.2 mg/mL)

Linked Drug Pages (1)

Milrinone Lactate in Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4522009c-38db-44c1-8d16-c44f674a9920", "openfda": {"upc": ["0368083410018", "0368083411015"], "unii": ["9K8XR81MO8"], "rxcui": ["1791840", "1791842"], "spl_set_id": ["838da14b-c070-4c09-b088-99e7c64d9964"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (68083-411-10)  / 1 BAG in 1 CARTON (68083-411-01)  / 200 mL in 1 BAG", "package_ndc": "68083-411-10", "marketing_start_date": "20200716"}], "brand_name": "Milrinone Lactate in Dextrose", "product_id": "68083-411_4522009c-38db-44c1-8d16-c44f674a9920", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "68083-411", "generic_name": "Milrinone Lactate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Milrinone Lactate in Dextrose", "active_ingredients": [{"name": "MILRINONE LACTATE", "strength": ".2 mg/mL"}], "application_number": "ANDA213585", "marketing_category": "ANDA", "marketing_start_date": "20200716", "listing_expiration_date": "20261231"}