FDA.reportPublic FDA data

Tobramycin

Product NDC
67457-473
11-digit product format
674570473
Labeler code
67457
Product ID
67457-473_7418acd9-03c9-40ed-bac0-1e0702c8114d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA065407
Marketing category
ANDA
Marketing start
2014-08-19
Substance
TOBRAMYCIN SULFATE
Active strength
40 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tobramycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN SULFATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHJT0RXD7JK
Rxcui597823

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-473-00Tobramycin2 mL in 1 VIALINJECTION27
67457-473-22Tobramycin25 in 1 CARTONINJECTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-473-00ML - Milliliter67457-4734ea93675-582b-41d0-ac4e-f973411a59cb12014-09-03
67457-473-22ML - Milliliter67457-473ca88adb7-7495-4a46-945e-28a781e2017b12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
PHENOLINACTIVE INGREDIENT339NCG44TVTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6ITOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-473TOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC]7Current NDC, Legacy NDC, 2 package rows20230105_ac8134d9-a726-4508-b8b9-a536ef17243d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNac8134d9-a726-4508-b8b9-a536ef17243d7
597823tobramycin 40 MG/ML Injectable SolutionSCDac8134d9-a726-4508-b8b9-a536ef17243d7
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYac8134d9-a726-4508-b8b9-a536ef17243d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-473-00674570473002 mL in 1 VIAL2 mlHistorical
67457-473-226745704732225 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00) 25 vial2014-08-190000-00-00NoNoCurrent