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 7 of 14 · 276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
D-10SEPIA OFFICINALIS WHOLE, SANGUINARIA CANADENSIS ROOT, SULFURIC ACID, BLACK COHOSH, AND LACHESIS MUTA VENOMDNA Labs, Inc.1e5ba502-eef4-4df0-8330-b70d1872b4bb2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: O40UQP6WCF
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: A2I8C7HI9T
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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