FDA.reportPublic FDA data

NDC 63323-173-01 - Gentamicin

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
63323-173
Requested NDC
63323-173-01
Package NDCs from labels
63323-173-95, 63323-173-41, 63323-173-94, 63323-173-01, 63323-173-02
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-14HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-12-20HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-10-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-173-01Gentamicin2 mL in 1 VIALINJECTION, SOLUTION28
63323-173-02Gentamicin25 in 1 TRAYINJECTION, SOLUTION258
63323-173-41Gentamicin2 mL in 1 VIALINJECTION, SOLUTION24
63323-173-94Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-173-95Gentamicin25 in 1 TRAYINJECTION, SOLUTION253
63323-173-95Gentamicin2 mL in 1 VIALINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20231215_be5b414e-d598-4721-80ee-5836156ad210.zip
63323-173GENTAMICIN (GENTAMICIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20240106_8bdeef7f-ad8e-46e0-a872-e945eae51d68.zip
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241017_63413469-c676-48a3-a945-7d2489b535ef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-173-01ML - Milliliter63323-173ced61a19-c526-4301-9865-ba40e8c2182012022-08-04
63323-173-02ML - Milliliter63323-1735fd11ec3-8c33-4c79-b4c7-bec645fb287312012-07-24
63323-173-41ML - Milliliter63323-173d5f59524-b9ee-4918-b264-40afffbbcc2e12023-01-09
63323-173-94ML - Milliliter63323-17353fc2922-96f5-4ce1-8684-be9e028a9a6e12013-12-02
63323-173-95ML - Milliliter63323-173f3a52ac6-ae2b-4af9-8def-100e9d3032b712014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, SANGUINARIA CANADENSIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, MEPHITIS MEPHITICADeseret Biologicals, Inc.22b6a444-68de-43a3-85e8-e8a74b3914bc2025-05-27WarningsExact identifier
unii: O40UQP6WCF
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: O40UQP6WCF
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM191KREOSOTUM, NITRIC ACID, SULPHUR, SULPHURIC ACID, URTICA URENBestmade Natural Products2ea7c2e5-73d6-6820-e063-6294a90aaf1c2025-02-21WarningsExact identifier
unii: O40UQP6WCF
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: O40UQP6WCF
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: O40UQP6WCF
Bestmade Natural Products BM115BORAX, CAPSICUM, CONDURANGO, HYDRASTIS MUR, KALI PERMANGANATUM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBestmade Natural Products2d901bf9-b71d-06b5-e063-6294a90a5e4a2025-02-07WarningsExact identifier
unii: O40UQP6WCF
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-28CLAVICEPS PURPUREA SCLEROTIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, SAFFRON, FERROSOFERRIC PHOSPHATE, SULFURIC ACID, AND HORSE CHESTNUTDNA Labs, Inc.2e75490a-b63d-419b-8e33-72e30faea4502025-01-13WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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