Tobramycin

Product NDC
36000-244
11-digit product format
360000244
Labeler code
36000
Product ID
36000-244_19ade85b-3da4-44af-8ad0-d68d15a48193
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA206965
Marketing category
ANDA
Marketing start
2016-07-15
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
36000-244-05Tobramycin5 in 1 BLISTER PACKINJECTION516
36000-244-05Tobramycin2 mL in 1 VIALINJECTION216
36000-244-10Tobramycin10 in 1 BLISTER PACKINJECTION1016
36000-244-10Tobramycin2 mL in 1 VIALINJECTION216
36000-244-25Tobramycin25 in 1 BLISTER PACKINJECTION2516
36000-244-25Tobramycin2 mL in 1 VIAL, MULTI-DOSEINJECTION216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-244-25ML - Milliliter36000-244a6db22f5-e1b0-4b68-a2e7-ae037cee782312016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-244TOBRAMYCIN INJECTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 6 package rows20240922_a9897444-71f6-42af-9b71-4aa77829ade0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNa9897444-71f6-42af-9b71-4aa77829ade016
597823tobramycin 40 MG/ML Injectable SolutionSCDa9897444-71f6-42af-9b71-4aa77829ade016
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYa9897444-71f6-42af-9b71-4aa77829ade016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36000-244-05360000244055 in 1 BLISTER PACKHistorical
36000-244-103600002441010 in 1 BLISTER PACKHistorical
36000-244-253600002442525 VIAL, MULTI-DOSE in 1 BLISTER PACK (36000-244-25) / 2 mL in 1 VIAL, MULTI-DOSE2016-07-150000-00-00NoNoCurrent