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 1 of 18 · 353 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
unii: 339NCG44TV
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
unii: 339NCG44TV
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
unii: 339NCG44TV
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
unii: 339NCG44TV
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
unii: 339NCG44TV
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: 339NCG44TV
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
unii: 339NCG44TV
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
unii: 339NCG44TV
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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