FDA.reportPublic FDA data

NDC 39822-0409-1 - 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
39822-0409
Requested NDC
39822-0409-1
Package NDCs from labels
39822-0409-1, 39822-0409-6
Manufacturer
X-GEN Pharmaceuticals, Inc.
Effective date
2015-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin for Injection USP, 1.2 gm†X-GEN Pharmaceuticals, Inc.2015-05-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39822-0409-62020-02-25C16284748780-19d75b9d0-c5c5-f424-e053-dadaa90a57ceTobramycin for Injection USP, 1.2 gm†
39822-0409-62020-01-31C16284748780-19d75b9d0-c5c5-f424-e053-dadaa90a57ceTobramycin for Injection USP, 1.2 gm†

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0409-1EA - Each39822-0409392d90e1-1d75-4673-902f-3bafa09f301612014-08-01
39822-0409-6EA - Each39822-04096b2df3ff-f073-4dc2-a453-f96192a07b8c12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]7
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]7

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM115 DROPSBORAX, CAPSICUM, CONDURANGO, HYDRASTIS CAN, KALI PERM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBM Private Limited532302ff-e18c-de15-e063-6394a90a2b1c2026-05-31WarningsExact identifier
unii: O40UQP6WCF
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
TOBRAMYCINTOBRAMYCINHospira, Inc.c5a005b0-7b6f-4e30-df92-9a20b1ca66a12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HJT0RXD7JK
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
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
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
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
unii: HJT0RXD7JK
Mold PlusAGARICUS MUSCARIUS, ALLIUM CEPA, AMMONIUM CARBONICUM, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.372ad9cc-70eb-4f3f-b611-69e2d157c0582026-02-23WarningsExact identifier
unii: O40UQP6WCF
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: O40UQP6WCF
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: O40UQP6WCF
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: O40UQP6WCF
Large Joint Pain Drops 2037LARGE JOINT PAIN DROPSProfessional Complementary Health Formulasb34b0fce-9b7a-4f64-b557-b9c0ad61187c2026-01-08WarningsExact identifier
unii: O40UQP6WCF
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: O40UQP6WCF
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: O40UQP6WCF
SlenderiixWEIGHT MANAGEMENT FORMULAVitality Works398251ec-6834-4dda-abc6-f503632d16322025-12-17WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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