FDA.reportPublic FDA data

NDC 67184-0570-02 - Amikacin Sulfate

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
67184-0570
Requested NDC
67184-0570-02
Package NDCs from labels
67184-0570-1, 67184-0570-2, 67184-0570-02
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amikacin Sulfate Injection, USP Rx onlyQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)2025-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0570-1Amikacin Sulfate4 mL in 1 VIAL, GLASSINJECTION, SOLUTION43
67184-0570-2Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0570AMIKACIN SULFATE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.]1Current NDC, 2 package rows20240326_20fa61ef-11e2-4d01-82ea-b5412cefaead.zip

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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
amikacin sulfateAMIKACIN SULFATESagent Pharmaceuticalsf260ff2a-76a0-4672-9516-91c344b678902026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM115 DROPSBORAX, CAPSICUM, CONDURANGO, HYDRASTIS CAN, KALI PERM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBM Private Limited532302ff-e18c-de15-e063-6394a90a2b1c2026-05-31WarningsExact identifier
unii: O40UQP6WCF
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.53f4232b-23d4-48dc-aa76-175fdebfc74f2026-05-06WarningsExact identifier
unii: O40UQP6WCF
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: O40UQP6WCF
Menopause ReliefAMYL NIT, CALC CARB, CAULOPHYLLUM, CIMICIFUGA, FERRUM MET, GELSEMIUM, LACHESIS, PULSATILLA, SANGUINARIA, SEPIA, SULPHUR AND SULPHURICUM AC.King Bio Inc.e12b75f5-6c5f-4b39-a6aa-dad07089f1d82026-03-10WarningsExact identifier
unii: O40UQP6WCF
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: O40UQP6WCF
Lungs and Bronchial ReliefAMMONIUM CARBONICUM, ANTIMONIUM ARSENICICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BROMIUM, CARBO VEGETABILIS, CHLORINUM, KALI CARBONICUM, LOBELIA INFLATA, STANNUM METALLICUM, SULPHURICUM ACIDUM.King Bio Inc.fc4d4a56-3483-4cae-9818-fdae4e95ec6c2026-03-02WarningsExact identifier
unii: O40UQP6WCF
Mold PlusAGARICUS MUSCARIUS, ALLIUM CEPA, AMMONIUM CARBONICUM, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.372ad9cc-70eb-4f3f-b611-69e2d157c0582026-02-23WarningsExact identifier
unii: O40UQP6WCF
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
Amikacin SulfateAMIKACIN SULFATEMullan Pharmaceutical Inc.840ba25a-d60c-4f0d-a084-71b0c68237df2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA218146
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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