FDA.reportPublic FDA data

NDC 67184-0611-01 - 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
67184-0611
Requested NDC
67184-0611-01
Package NDCs from labels
67184-0611-1, 67184-0611-2, 67184-0611-01
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
Effective date
2025-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicardipine HydrochlorideQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.2025-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0611-1Nicardipine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION109
67184-0611-2Nicardipine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION109

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 6 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.7433b5cd-9c3a-428a-bcaf-00f02cd526332025-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA219608
ndc (package): 67184-0611-2
ndc (package): 67184-0611-1
ndc (product): 67184-0611
ndc11 (package): 67184061101
rxcui: 858607
spl id: ea3b2399-f7da-417a-aa1d-b4525235b820
spl set id: 7433b5cd-9c3a-428a-bcaf-00f02cd52633
unii: K5BC5011K3
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECipla USA Inc.570af1f8-6718-4b40-ae89-0f738d330ebd2025-04-08Warnings, Adverse reactionsExact identifier
unii: K5BC5011K3

Reported adverse events (FAERS/openFDA)#

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