NDC 63323-010-01 - 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
63323-010
Requested NDC
63323-010-01
Package NDCs from labels
63323-010-96, 63323-010-41, 63323-010-94, 63323-010-42, 63323-010-95, 63323-010-01, 63323-010-02, 63323-010-03, 63323-010-20
Manufacturer
Henry Schein, Inc
Effective date
2025-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin - Henry Schein, IncHenry Schein, Inc2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-11HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Injection, USPREMEDYREPACK INC.2024-10-10HUMAN PRESCRIPTION DRUG LABEL
GENTAMICIN - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-11-10HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-10-31HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-10-20HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-010-01Gentamicin2 mL in 1 VIALINJECTION, SOLUTION27
63323-010-02Gentamicin25 in 1 TRAYINJECTION, SOLUTION257
63323-010-03Gentamicin20 mL in 1 VIALINJECTION, SOLUTION207
63323-010-20Gentamicin25 in 1 TRAYINJECTION, SOLUTION257
63323-010-41Gentamicin2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION24
63323-010-42Gentamicin20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION204
63323-010-94Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-010-95Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-010-96Gentamicin25 in 1 TRAYINJECTION, SOLUTION253
63323-010-96Gentamicin20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 4 package rows20231215_a73a5453-c091-43fd-aae2-d992152363b1.zip
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 4 package rows20231219_0cce2238-28d3-4280-b520-ffc3067a2ffa.zip
63323-010GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241017_84f5c763-1cd3-4d85-9afb-934db8666fbf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-010-01ML - Milliliter63323-0108f7fbb9f-e4ee-4c24-9cbf-cf5bb8b1d5fa12021-11-09
63323-010-02ML - Milliliter63323-01092538238-da65-4ed7-8897-630760fe2e7c12013-02-13
63323-010-03ML - Milliliter63323-01019616f55-e7a5-4305-8fdd-aa5fe3efe73c12021-10-08
63323-010-20ML - Milliliter63323-010c14a0d40-777c-4160-864c-67db4bc4ef4312013-02-13
63323-010-41ML - Milliliter63323-0104a00898e-ee4d-42cf-ac5d-a838db4deae912021-11-09
63323-010-42ML - Milliliter63323-01012f4a20a-beb2-4941-b432-2e768988c15512021-11-09
63323-010-94ML - Milliliter63323-01068aa80b2-bd39-4e78-ba34-50985d84379c12013-12-02
63323-010-95ML - Milliliter63323-0102f852c4c-085f-4c84-ab61-7553ed9f830c12013-12-02
63323-010-96ML - Milliliter63323-010fc20bbf7-9d1b-4004-a475-7c44486c15dd12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]5
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]5
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN (GENTAMICIN SULFATE) 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 3 of 14 · 276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
GentamicinGENTAMICINEugia US LLC60ca1487-392d-4721-aa45-3de38722896c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313996
unii: 8X7386QRLV
GentamicinGENTAMICINEugia US LLCf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: O40UQP6WCF
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: O40UQP6WCF
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: O40UQP6WCF
Large Joint Pain Drops 2037LARGE JOINT PAIN DROPSProfessional Complementary Health Formulasb34b0fce-9b7a-4f64-b557-b9c0ad61187c2026-01-08WarningsExact identifier
unii: O40UQP6WCF
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: O40UQP6WCF
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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