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 7 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicalsdfc114e0-34d4-4ae4-bba8-a8a1b7ad6a242024-10-23WarningsExact identifier
unii: O40UQP6WCF
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
GentamicinGENTAMICINFresenius Kabi USA, LLC63413469-c676-48a3-a945-7d2489b535ef2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062366
ndc (package): 63323-173-95
ndc (product): 63323-173
rxcui: 1870676
spl id: 9f48c9f7-08fd-4652-911c-c2c221a34ed3
spl set id: 63413469-c676-48a3-a945-7d2489b535ef
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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