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 3 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.53f4232b-23d4-48dc-aa76-175fdebfc74f2026-05-06WarningsExact identifier
unii: O40UQP6WCF
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
71346018-1beb-4105-8082-f600c4515d700b4a4b00-7f78-4e95-b870-f88fea73348e2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 0b4a4b00-7f78-4e95-b870-f88fea73348e
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
unii: 339NCG44TV
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
unii: 339NCG44TV
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: 339NCG44TV
TOBRAMYCINTOBRAMYCINHospira, Inc.c5a005b0-7b6f-4e30-df92-9a20b1ca66a12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: 339NCG44TV
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
unii: 339NCG44TV
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: O40UQP6WCF
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Menopause ReliefAMYL NIT, CALC CARB, CAULOPHYLLUM, CIMICIFUGA, FERRUM MET, GELSEMIUM, LACHESIS, PULSATILLA, SANGUINARIA, SEPIA, SULPHUR AND SULPHURICUM AC.King Bio Inc.e12b75f5-6c5f-4b39-a6aa-dad07089f1d82026-03-10WarningsExact identifier
unii: O40UQP6WCF
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
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
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: 339NCG44TV
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
TobramycinTOBRAMYCINXiromed LLC8b50d1b5-ea8a-5844-358a-493f1965c07f2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
unii: 339NCG44TV

Reported adverse events (FAERS/openFDA)#

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