FDA.reportPublic FDA data

NDC 0517-0735-01 - 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
0517-0735
Requested NDC
0517-0735-01
Package NDCs from labels
0517-0735-01, 0517-0735-10
Manufacturer
American Regent, Inc.
Effective date
2020-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicardipine Hydrochloride - American Regent, Inc.American Regent, Inc.2020-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0735-01Nicardipine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION109
0517-0735-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0735NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]9Current NDC, Legacy NDC, 2 package rows20201209_76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0735-01ML - Milliliter0517-0735f904440f-8fb1-4fc3-9a34-c1bdf335071012020-06-05
0517-0735-10ML - Milliliter0517-0735623296fd-3402-4c26-b03a-aaee8e44ebd812020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RNICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]3

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9d898911-d811-2a78-e053-2995a90af7842025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 506T60A25R
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEArchis Pharma LLCd0070638-bea5-413a-8658-4c752c6104f52024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEBionpharma Inc.7bed5d8c-30c2-4598-acf3-2edba825a56d2024-11-04Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 2968PHW8QP
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 506T60A25R
Nicardipine hydrochlorideNICARDIPINEAmneal Pharmaceuticals NY LLC79304b0f-53d3-4065-8c81-7031d11416942024-10-03Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.18fb1c2b-0c1e-436c-a5b6-d4840b5da2282024-08-24Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEArmas Pharmaceuticals Inc.7226a518-164b-4755-9624-1cc75c9390632024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEEpic Pharma, LLCb8f147b8-955f-4733-9178-2cfa0beb60d62023-12-27Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEBurel Pharmaceuticals, LLCcb902af0-b5ad-4680-b2f2-007ef2196efe2023-09-07Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3

Reported adverse events (FAERS/openFDA)#

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