FDA.reportPublic FDA data

NDC 63323-306-01 - Tobramycin

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
63323-306
Requested NDC
63323-306-01
Package NDCs from labels
63323-306-26, 63323-306-01, 63323-306-02, 63323-306-05, 63323-306-30
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-03-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-03-29HUMAN PRESCRIPTION DRUG LABEL
Tobramycin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-02-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-306-01Tobramycin2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION27
63323-306-02Tobramycin25 in 1 TRAYINJECTION, SOLUTION257
63323-306-05Tobramycin30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION307
63323-306-30Tobramycin10 in 1 TRAYINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-306TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 4 package rows20240302_d6dd9460-b030-479a-b3e3-03606e6fcad1.zip
63323-306TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC20240402_0b4a4b00-7f78-4e95-b870-f88fea73348e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-306-01ML - Milliliter63323-30632d8a91f-0441-4b5b-9ba7-9d919b23668a12024-08-12
63323-306-02ML - Milliliter63323-3063253bbde-aa65-4597-9fd2-58f18237b6c012013-02-13
63323-306-05ML - Milliliter63323-3064fb1fc7c-b01b-4544-8f72-171a4df8166412025-02-10
63323-306-26ML - Milliliter63323-3068cae4f7f-f64a-4c85-97f6-58ac3cd1a39312019-12-10
63323-306-30ML - Milliliter63323-306fa2f483e-ba48-4530-9462-63deb6cf2dfb12013-02-13
63323-306-55ML - Milliliter63323-3067d1b10a8-315f-4521-910c-1e97dc51206712013-06-04
63323-306-56ML - Milliliter63323-306f01c736c-ca51-4ae5-bc4a-b94242e4a64812013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PHENOLINACTIVE INGREDIENT339NCG44TVTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

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 8 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhytogelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, RHUS TOX, SULPHURICUM ACIDUM, SYMPHYTUM OFFICINALEEnergetix Corporatione94b4f4c-bf4e-4210-a4e1-f2b7341e6dcc2025-07-15WarningsExact identifier
unii: O40UQP6WCF
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: 339NCG44TV
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MenopauseANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.03ce1f50-6af5-4640-825f-67fcb25e76e62025-06-24WarningsExact identifier
unii: O40UQP6WCF
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
unii: 339NCG44TV
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: 339NCG44TV
unii: O40UQP6WCF
MetDetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Dr. Donna Restivo DC89ce5e89-c592-445e-92f9-365133005fb32025-05-23WarningsExact identifier
unii: 339NCG44TV
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
unii: 339NCG44TV
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
Bestmade Natural Products Carbolic AcidACID CARBOLICUMBestmade Natural Products2f962dd1-40b7-cebe-e063-6394a90a92ac2025-03-05WarningsExact identifier
unii: 339NCG44TV
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

Reported adverse events (FAERS/openFDA)#

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