FDA.reportPublic FDA data

NDC 23360-014 - 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
23360-014
Package NDCs from labels
23360-014-02, 23360-014-30
Manufacturer
Akorn - Strides, LLC
Effective date
2008-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Akorn - Strides, LLCAkorn - Strides, LLC2008-03-11HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23360-014-02Tobramycin25 in 1 CASEINJECTION251
23360-014-02Tobramycin2 mL in 1 VIALINJECTION21
23360-014-30Tobramycin1 in 1 CASEINJECTION11
23360-014-30Tobramycin30 mL in 1 VIALINJECTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23360-014TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]14 package rows20080325_49151A62-191A-4BA8-8B8C-BD8535F2FDB3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tobramycin sulfateACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
PHENOLINACTIVE INGREDIENT339NCG44TVTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6ITOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION [AKORN - STRIDES, LLC]1

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 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCINTOBRAMYCINHospira, Inc.c5a005b0-7b6f-4e30-df92-9a20b1ca66a12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINXiromed LLC8b50d1b5-ea8a-5844-358a-493f1965c07f2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
tobramycinTOBRAMYCINSlate Run Pharmaceuticals, LLCed254eec-10f4-425a-895b-66e325b7bf692026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINXGen Pharmaceuticals DJB, Inc.a384641c-04e3-4ab5-b152-7408cd07b64d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINNorthstar Rx LLC55d09ffd-4f32-8aeb-3904-8a17db635e3a2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TOBRAMYCINTOBRAMYCINEugia US LLCc37c251f-92e9-40f0-8b0c-00d42875d7762024-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLC9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd6dd9460-b030-479a-b3e3-03606e6fcad12024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd62ff359-912b-4be1-9fc2-2dde8777eefb2024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINBaxter Healthcare Corporationa9897444-71f6-42af-9b71-4aa77829ade02023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINGland Pharma Limited645d34d9-275d-428e-863d-ae15ad009c442023-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINGland Pharma Limited02b48684-168c-4cd9-8375-794206eff23e2023-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINFosun Pharma USA Incc4751a4f-c9c1-60c5-e053-2995a90aeba92022-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINMylan Institutional LLCac8134d9-a726-4508-b8b9-a536ef17243d2022-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINGland Pharma Limited38219f34-4859-428f-9ec1-06ead76042112022-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
4FE06463-19DE-FEF3-B900-156268D090B049151A62-191A-4BA8-8B8C-BD8535F2FDB32008-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 4FE06463-19DE-FEF3-B900-156268D090B0
spl set id: 49151A62-191A-4BA8-8B8C-BD8535F2FDB3

Reported adverse events (FAERS/openFDA)#

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