FDA.reportPublic FDA data

NDC 42677-314-01 - Milrinone Lactate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42677-314
Requested NDC
42677-314-01
Package NDCs from labels
42677-314-01, 42677-314-10
Manufacturer
Shandong New Time Pharmaceutical Co., Ltd.
Effective date
2026-06-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Milrinone Lactate Injection, USP Rx onlyShandong New Time Pharmaceutical Co., Ltd.2026-06-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42677-314-01Milrinone Lactate20 mL in 1 VIALINJECTION, SOLUTION205
42677-314-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42677-314MILRINONE LACTATE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]4Current NDC, 2 package rows20241127_0fdaee3c-2144-4ca7-9868-54d251f468c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Milrinone LactateMILRINONE LACTATEMullan Pharmaceutical Inc.07dddead-22ed-004c-e063-6294a90a76fc2026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA216373
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Milrinone Lactate in 5% DextroseMILRINONE LACTATE IN 5% DEXTROSECaplin Steriles Limiteda2822b12-0560-49d6-ace5-2377c04425e82026-06-25Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.