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 1 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.372a4381-7302-4df7-81bb-a9521907f8672026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEMicro Labs Limited8e8611e0-7d8c-4f30-b53a-76c6588b6ef72026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmerisyn LLC575c5dab-e832-192a-e063-6294a90a34a12026-07-24Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDECaplin Steriles Limited9383f1dc-0310-4c87-a8f0-48c09a85d89b2026-06-25Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 506T60A25R
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
Nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDELifestar Pharma LLCb0e2bed3-f928-43ab-a05c-275bedc9856f2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 858607
unii: K5BC5011K3
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESomerset Therapeutics, LLCf8b49f59-7a54-425d-9eca-dfa4022a08d12026-04-20Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationa3e33add-0d09-423a-9109-42e5ba7148d52026-04-13Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
Cardene IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporation5499cfac-9147-4d5d-a8cb-f8d64f1481af2026-04-13Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e2026-03-27Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3

Reported adverse events (FAERS/openFDA)#

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