FDA.reportPublic FDA data

NDC 63323-617-01 - 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
63323-617
Requested NDC
63323-617-01
Package NDCs from labels
63323-617-01, 63323-617-10, 63323-617-50, 63323-617-02, 63323-617-20
Manufacturer
Fresenius Kabi USA, LLC | HuZhou ZhanWang Pharmaceutical Co., Ltd
Effective date
2023-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MILRINONE - Fresenius Kabi USA, LLC | HuZhou ZhanWang Pharmaceutical Co., LtdFresenius Kabi USA, LLC | HuZhou ZhanWang Pharmaceutical Co., Ltd2023-03-17Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-617-01Milrinone Lactate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
63323-617-02Milrinone Lactate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION206
63323-617-10Milrinone Lactate10 in 1 TRAYINJECTION, SOLUTION106
63323-617-20Milrinone Lactate10 in 1 TRAYINJECTION, SOLUTION106
63323-617-50Milrinone Lactate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION506
63323-617-50Milrinone Lactate1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-617MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 6 package rows20230406_ac43ba6b-635d-4129-8eea-96f3f5a4785e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-617-01ML - Milliliter63323-6170164d2fb-de7f-4c87-b54e-11fc54147a5c12025-10-14
63323-617-02ML - Milliliter63323-617c6fd8e0d-3eb0-4bee-9750-5b5ba37ca75812025-07-08
63323-617-10ML - Milliliter63323-61712c104a6-1d54-406c-8c8c-3fdc9afb4b6812013-02-13
63323-617-20ML - Milliliter63323-617a4d179e4-e0ad-4534-875a-9cc80d9f3e8712013-02-13
63323-617-50ML - Milliliter63323-617a67f1b90-71ee-4f8f-b4eb-e491aee4bdf412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CirculationCACTUS GRANDIFLORUS, KALI CARBONICUM, KALMIA LATIFOLIA, ARNICA MONTANA, GLONOINUM, IGNATIA AMARA, LACTICUM ACIDUM, RANUNCULUS BULBOSUS, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, FUMARICUM ACIDUM, HEART (SUIS), HEPAR SUIS, MALICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUS, STROPHANTHUS HISPIDUS, SPIGELIA ANTHELMIA, CARBO VEGETABILIS, NAJA TRIPUDIANS, CYTOMEGALOVIRUS NOSODE, EPSTEIN-BARR VIRUS NOSODEDeseret Biologicals, Inc.29f30a6a-406d-4fb4-850d-d33486fbafe42024-04-18WarningsExact identifier
unii: 33X04XA5AT
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.b3c936b3-5c86-4d87-9544-e94e95d0245f2023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 33X04XA5AT
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 33X04XA5AT
PancreaparSYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMEnergique, Inc.ba9c13d0-92de-4159-8a35-215e3de50c072023-08-24WarningsExact identifier
unii: 33X04XA5AT
Milrinone LactateMILRINONE LACTATEArmas Pharmaceuticals Inc.fde1e354-4f15-4ade-9ae3-db2ba67e04312023-04-05Warnings, Adverse reactionsExact identifier
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATEFresenius Kabi USA, LLCac43ba6b-635d-4129-8eea-96f3f5a4785e2023-03-17Warnings, Adverse reactionsExact identifier
application number: ANDA075936
ndc (package): 63323-617-10
ndc (package): 63323-617-20
ndc (package): 63323-617-02
ndc (package): 63323-617-01
ndc (package): 63323-617-50
ndc (product): 63323-617
ndc11 (package): 63323061701
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
spl id: 7ada1876-c47a-4e3e-bd48-a6a1f486b517
spl set id: ac43ba6b-635d-4129-8eea-96f3f5a4785e
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATE IN 5% DEXTROSEEugia US LLC4e489fab-75bc-4514-9bf2-85b8ed08a1b02023-02-01Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATESomerset Therapeutics, LLCce43e850-4e80-4c5b-8811-9cb65824768c2022-09-23Warnings, Adverse reactionsExact identifier
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
Milrinone Lactate in DextroseMILRINONE LACTATE IN DEXTROSEHospira, Inc.5273ea17-6920-4bff-8c5b-20ea531a04232022-03-28Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATEMeitheal Pharmaceuticals Inc.6c6b69f9-e229-4a93-a108-9eafdab614f02022-01-13Warnings, Adverse reactionsExact identifier
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
Milrinone Lactate in DextroseMILRINONE LACTATEGland Pharma Limited838da14b-c070-4c09-b088-99e7c64d99642021-08-25Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Milrinone Lactate in DextroseMILRINONE LACTATESagent Pharmaceuticalsbb0157d0-a414-43fa-81e0-8c92d717f1b22020-11-20Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
OMEOSPORT.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -Guna spa119a205d-0074-48ff-ac78-e2300db452272018-12-21WarningsExact identifier
unii: 33X04XA5AT
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.bb7500f8-dbfd-4c8a-ac2e-5533609c39702018-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1791859
unii: 9K8XR81MO8
Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare Corporation8fd0f93a-6150-4020-b7ee-4b95b520f6ce2018-05-30Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Glucose Control T015SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMGuangzhou Renuma Medical Systems Co., Ltd3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b2017-10-26WarningsExact identifier
unii: 33X04XA5AT

Reported adverse events (FAERS/openFDA)#

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