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#

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 9 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GENTAMICINGENTAMICINHF Acquisition Co LLC, DBA HealthFirstc1ff0cdc-ac5d-30ca-e053-2a95a90a50662024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062366
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsExact identifier
unii: 8X7386QRLV
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
N02 PETROCHEMACETONE, ANILINUM, BENZINUM, BENZOPYRENE, CARBO VEGETABILIS, CARBOLICUM ACIDUM, CARBON TETRACHLORIDE, ETHER, MAGNESIA SULPHURICA, METHYL ALCOHOL, PETROLEUM, PHENOLPHTHALEIN, PHOSPHORUS, PICRICUM ACIDUM, PINE TAR, PLUMBOUS CHLORIDE, PLUMBUM METALLICUM, SULPHONALUM, SULPHURICUM ACIDUM, TEREBINTHINA, TRICHLOROETHYLENE, VANADIUM METALLICUMApex Energetics Inc.ba5e7801-667b-ab7c-e053-2995a90a788c2024-01-08WarningsExact identifier
unii: O40UQP6WCF
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
GentamicinGENTAMICINFresenius Kabi USA, LLC8bdeef7f-ad8e-46e0-a872-e945eae51d682023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062366
ndc (package): 63323-173-41
ndc (package): 63323-173-94
ndc (product): 63323-173
rxcui: 1870676
spl id: aa0e7e88-2ae5-4527-888b-983fb4580ac2
spl set id: 8bdeef7f-ad8e-46e0-a872-e945eae51d68
unii: 8X7386QRLV
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 Biologicals6051c9d5-36ef-4bfa-baab-9862c94805fb2023-12-12WarningsExact identifier
unii: O40UQP6WCF
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, SANGUINARIA CANADENSIS, BLATTA ORIENTALIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGERDeseret Biologicals, Inc.795c34c6-71c8-4c36-b441-4bca55a435752023-12-04WarningsExact identifier
unii: O40UQP6WCF
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
unii: 8X7386QRLV
Sulphuricum acidumSULFURIC ACIDBoiron8692f851-0484-fa7d-e053-2991aa0a8e572023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8692a44d-2f50-d574-e053-2991aa0a7ee62023-11-15Exact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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