FDA.reportPublic FDA data

Tobramycin

Product NDC
63323-306
11-digit product format
633230306
Labeler code
63323
Product ID
63323-306_c55fcee9-70c7-4926-bee6-014c0b133249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOBRAMYCIN SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065122
Marketing category
ANDA
Marketing start
2005-11-23
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
Rxcui313416, 597823

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
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313416tobramycin 10 MG/ML Injectable SolutionPSNd6dd9460-b030-479a-b3e3-03606e6fcad17
597823tobramycin 40 MG/ML Injectable SolutionPSNd6dd9460-b030-479a-b3e3-03606e6fcad17
313416tobramycin 10 MG/ML Injectable SolutionSCDd6dd9460-b030-479a-b3e3-03606e6fcad17
597823tobramycin 40 MG/ML Injectable SolutionSCDd6dd9460-b030-479a-b3e3-03606e6fcad17
313416tobramycin (as tobramycin sulfate) 10 MG/ML Injectable SolutionSYd6dd9460-b030-479a-b3e3-03606e6fcad17
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYd6dd9460-b030-479a-b3e3-03606e6fcad17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-306-01633230306012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
63323-306-026332303060225 VIAL, MULTI-DOSE in 1 TRAY (63323-306-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-306-01) 2005-11-230000-00-00NoNoCurrent
63323-306-056332303060530 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
63323-306-266332303062625 VIAL, MULTI-DOSE in 1 TRAY (63323-306-26) > 2 mL in 1 VIAL, MULTI-DOSE2005-11-230000-00-00NoNoCurrent
63323-306-306332303063010 VIAL, MULTI-DOSE in 1 TRAY (63323-306-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-306-05) 2005-11-230000-00-00NoNoCurrent