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 10 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
Acidum SulphuricumACIDUM SULPHURICUMHahnemann Laboratories, INC.038c2235-b113-963d-e063-6394a90a2b102023-08-22Exact identifier
unii: O40UQP6WCF
Fem Flora DefenseBAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.8015e1cb-9ebd-4b3e-af57-92f2754fb7902023-08-17WarningsExact identifier
unii: O40UQP6WCF
Clearlife Extra StrengthONION, AMBROSIA ARTEMISIIFOLIA WHOLE, APIS MELLIFERA, ARNICA MONTANA WHOLE, EUPHRASIA STRICTA, GRAPHITE,GALPHIMIA GLAUCA FLOWERING TOP,PULSATILLA VULGARIS WHOLE, HISTAMINE DIHYDROCHLORIDE, PINE TAR, SCHOENOCAULON OFFICINALE SEED, SULFUR, SULFURIC ACID,TELLURIUM AND THUJA OCCIDENTALIS LEAFY TWIGMediNatura Inc.088ba0ac-8ffa-4057-8286-88765c228f392023-06-05WarningsExact identifier
unii: O40UQP6WCF
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TobramycinTOBRAMYCINBaxter Healthcare Corporationa9897444-71f6-42af-9b71-4aa77829ade02023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINGland Pharma Limited645d34d9-275d-428e-863d-ae15ad009c442023-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209621
ndc (package): 68083-254-25
ndc (package): 68083-254-01
ndc (package): 68083-253-01
ndc (package): 68083-253-25
ndc (product): 68083-253
ndc (product): 68083-254
ndc11 (package): 68083025301
rxcui: 597823
rxcui: 313416
spl id: 5af7f80d-4d6d-404f-9ff7-1a8315625d8b
spl set id: 645d34d9-275d-428e-863d-ae15ad009c44
unii: HJT0RXD7JK
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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