FDA.reportPublic FDA data

Tobramycin

Product NDC
42571-408
11-digit product format
425710408
Labeler code
42571
Product ID
42571-408_38f21173-d355-80a7-e063-6294a90a3643
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin solution
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Micro Labs Limited
Application
ANDA217344
Marketing category
ANDA
Marketing start
2024-01-01
Substance
TOBRAMYCIN
Active strength
300 mg/5mL
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
TOBRAMYCIN300 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui348719

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
42571-408-09Tobramycin5 mL in 1 AMPULEINHALANT53
42571-408-19Tobramycin4 in 1 POUCHINHALANT43
42571-408-92Tobramycin14 in 1 CARTONINHALANT143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-408-09ML - Milliliter42571-408a069bc17-71f0-4ee9-b9c5-cd43d1cc91c012024-05-16
42571-408-19ML - Milliliter42571-408230ffc23-22ee-47d9-8900-7cd7bad4801412024-05-16
42571-408-92ML - Milliliter42571-408f4adfe8e-7fe4-4e6c-9eb0-b8672fd763b112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-408TOBRAMYCIN (TOBRAMYCIN SOLUTION) INHALANT [MICRO LABS LIMITED]2Current NDC, 3 package rows20240927_9d8b7b6c-3072-48e9-87c8-51160b9df9bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSN9d8b7b6c-3072-48e9-87c8-51160b9df9bc3
348719tobramycin 60 MG/ML Inhalation SolutionSCD9d8b7b6c-3072-48e9-87c8-51160b9df9bc3
348719tobramycin 300 MG per 5 ML Inhalation SolutionSY9d8b7b6c-3072-48e9-87c8-51160b9df9bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-408-09425710408095 mL in 1 AMPULE5 mlHistorical
42571-408-19425710408194 in 1 POUCHHistorical
42571-408-924257104089214 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) 14 pouch2024-01-01NoNoCurrent