FDA.reportPublic FDA data

NDC 55150-183-01 - NICARDIPINE HYDROCHLORIDE

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
55150-183
Requested NDC
55150-183-01
Package NDCs from labels
55150-183-02, 55150-183-11, 55150-183-01, 55150-183-10
Manufacturer
Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2023-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NICARDIPINE HYDROCHLORIDE - Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITEDEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2023-06-23Human Prescription Drug Label
NICARDIPINE HYDROCHLORIDE - Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITEDEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2021-10-11Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-183-01NICARDIPINE HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION103
55150-183-10NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION103
55150-183-02NICARDIPINE HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
55150-183-11NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-183NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20240507_dcd7d173-4d8e-4282-9edf-817711340e43.zip
55150-183NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]2Current NDC, Legacy NDC, 2 package rows20250509_9f5d3050-9cdf-404f-ac0f-72399178959f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-183-01ML - Milliliter55150-183fc606329-0883-47ed-8fcb-8f9844d9cf9412021-07-15
55150-183-02ML - Milliliter55150-18396491fcd-30e0-4273-9838-eb5157671ac712022-04-06
55150-183-10ML - Milliliter55150-18387a34569-d42d-4028-ad5b-1b469d0fccb112021-07-15
55150-183-11ML - Milliliter55150-1831735e43f-8abc-4d4e-bc50-3fece9de847a12022-04-06

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 13 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEAmerican Regent, Inc.76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a2020-05-01Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDECivica, Inc.30fb3a4d-fa75-42fd-b4b6-2a21f202027f2020-05-01Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals065efabf-8c7d-4dd5-aef2-700c2eca399d2019-01-07Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp0eb7d839-63d9-4b51-bf7b-4a8fde6339b52018-12-12Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 506T60A25R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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