milrinone lactate

Generic: milrinone lactate

Labeler: shandong new time pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name milrinone lactate
Generic Name milrinone lactate
Labeler shandong new time pharmaceutical co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

milrinone lactate 1 mg/mL

Manufacturer
Shandong New Time Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 42677-313
Product ID 42677-313_47b2ea09-87c3-2314-e063-6294a90a58b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216373
Listing Expiration 2027-12-31
Marketing Start 2023-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42677313
Hyphenated Format 42677-313

Supplemental Identifiers

RxCUI
1791854 1791859
UPC
0342677313015 0342677314012
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 (42677-313-10) / 10 mL in 1 VIAL (42677-313-01)
source: ndc

Packages (1)

42677-313-10 10 VIAL in 1 CARTON (42677-313-10) / 10 mL in 1 VIAL (42677-313-01)

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": "47b2ea09-87c3-2314-e063-6294a90a58b8", "openfda": {"upc": ["0342677313015", "0342677314012"], "unii": ["9K8XR81MO8"], "rxcui": ["1791854", "1791859"], "spl_set_id": ["0fdaee3c-2144-4ca7-9868-54d251f468c0"], "manufacturer_name": ["Shandong New Time Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42677-313-10)  / 10 mL in 1 VIAL (42677-313-01)", "package_ndc": "42677-313-10", "marketing_start_date": "20230301"}], "brand_name": "Milrinone Lactate", "product_id": "42677-313_47b2ea09-87c3-2314-e063-6294a90a58b8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 3 Inhibitor [EPC]", "Phosphodiesterase 3 Inhibitors [MoA]"], "product_ndc": "42677-313", "generic_name": "Milrinone Lactate", "labeler_name": "Shandong New Time Pharmaceutical Co., Ltd.", "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": "20230228", "listing_expiration_date": "20271231"}