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 5 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Bio Biological DetoxECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PROPOLIS, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYMUS SERPYLLUM, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYROIDINUM (SUIS), BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, PYROGENIUM, ANTHRACINUM, ARSENICUM, CARBOLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, LACHESIS, VARIOLINUM, BOTULINUM, DYSENTERY BACILLUS, GAERTNER BACILLUS, FRANCISELLA TULARENSIS, COXIELLA BURNETII, LAC CANINUM, MALARIA OFFICINALIS,BioActive Nutritional, Inc.9a6671bb-b070-4f97-bdc0-189cf60407ee2025-12-30WarningsExact identifier
unii: 339NCG44TV
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Absorbine Jr. Pro RollonABSORBINE JR. PRO ROLLONClarion Brands, LLC470efcd0-d350-3dc4-e063-6394a90ab8c12025-12-28WarningsExact identifier
unii: 339NCG44TV
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
HivesECHINACEA ANG, APIS MEL, ARSENICUM ALB, CARBOLICUM AC, LEDUM, RHUS TOX, SULPHUR, URTICA URENSNatural Creations, Incc453ac40-1865-4297-b7d4-c8e637bb5f942025-12-16WarningsExact identifier
unii: 339NCG44TV
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
unii: 339NCG44TV
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
unii: 339NCG44TV
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
unii: 339NCG44TV
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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