FDA.reportPublic FDA data

NDC 68083-253-01 - 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
68083-253
Requested NDC
68083-253-01
Package NDCs from labels
68083-253-01, 68083-253-25
Manufacturer
Gland Pharma Limited
Effective date
2023-03-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Gland Pharma LimitedGland Pharma Limited2023-03-09Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-253-01Tobramycin2 mL in 1 VIAL, MULTI-DOSEINJECTION27
68083-253-25Tobramycin25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-253TOBRAMYCIN INJECTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20230310_645d34d9-275d-428e-863d-ae15ad009c44.zip

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 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: O40UQP6WCF
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLC9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd6dd9460-b030-479a-b3e3-03606e6fcad12024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
rxcui: 313416
unii: HJT0RXD7JK
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
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd62ff359-912b-4be1-9fc2-2dde8777eefb2024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
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
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact 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 Biologicals6051c9d5-36ef-4bfa-baab-9862c94805fb2023-12-12WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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