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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-0735-01	Nicardipine Hydrochloride	10 mL in 1 VIAL	INJECTION, SOLUTION	10		9
0517-0735-10	Nicardipine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0735	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20201209_76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0735-01	ML - Milliliter	0517-0735	f904440f-8fb1-4fc3-9a34-c1bdf3350710	1	2020-06-05
0517-0735-10	ML - Milliliter	0517-0735	623296fd-3402-4c26-b03a-aaee8e44ebd8	1	2020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICARDIPINE HYDROCHLORIDE	ACTIVE INGREDIENT	K5BC5011K3	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICARDIPINE 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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lipotox	SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,	BioActive Nutritional, Inc.	a1538692-ca00-4e52-9b7e-409767ee27e1	2023-09-05	Warnings	Exact identifier unii: 506T60A25R
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier unii: 506T60A25R
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Eugia US LLC	9f5d3050-9cdf-404f-ac0f-72399178959f	2023-06-23	Warnings, Adverse reactions	Exact identifier rxcui: 858607 unii: K5BC5011K3
ChemDetox	BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM	Dr. Donna Restivo DC	2a17f80d-12c0-43a0-980b-9da648e9b76a	2023-01-10	Warnings	Exact identifier unii: 506T60A25R
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Eugia US LLC	dcd7d173-4d8e-4282-9edf-817711340e43	2021-10-11	Warnings, Adverse reactions	Exact identifier rxcui: 858607 unii: K5BC5011K3
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	55bd6dcc-1f12-4378-8e9e-1ceed26818f5	2021-07-21	Warnings, Adverse reactions	Exact identifier rxcui: 858607 unii: K5BC5011K3
GUNA FLAM RELIEF	ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -	Guna spa	af5a9c74-e1c7-6574-e053-2995a90a3d10	2020-09-15	Warnings	Exact identifier unii: 2968PHW8QP
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	American Regent, Inc.	76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a	2020-05-01	Warnings, Adverse reactions	Exact identifier application number: ANDA090534 ndc (package): 0517-0735-10 ndc (package): 0517-0735-01 ndc (product): 0517-0735 ndc11 (package): 00517073501 rxcui: 858607 spl id: 92ab3adc-2097-490a-a0b3-fa3fac098a2a spl set id: 76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a unii: K5BC5011K3
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Civica, Inc.	30fb3a4d-fa75-42fd-b4b6-2a21f202027f	2020-05-01	Warnings, Adverse reactions	Exact identifier application number: ANDA090534 rxcui: 858607 unii: K5BC5011K3
Sorbitol	SORBITOL	Baxter Healthcare Corporation	aea0b5a1-444b-4330-a3ce-26485dbbfe75	2019-12-31	Warnings, Adverse reactions	Exact identifier unii: 506T60A25R
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	065efabf-8c7d-4dd5-aef2-700c2eca399d	2019-01-07	Warnings, Adverse reactions	Exact identifier unii: K5BC5011K3
GUNA-ALLERGY-PREV	AMBROSIA 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 spa	adae93c0-1de9-4e45-ab58-148171f0dc86	2018-12-21	Warnings	Exact identifier unii: 2968PHW8QP
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp	0eb7d839-63d9-4b51-bf7b-4a8fde6339b5	2018-12-12	Warnings, Adverse reactions	Exact identifier rxcui: 858607 unii: K5BC5011K3
Homeoplex D	GLYCERINUM, 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-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: 506T60A25R

Reported adverse events (FAERS/openFDA)#

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