FDA.reportPublic FDA data

Tobramycin

Product NDC
47335-171
11-digit product format
473350171
Labeler code
47335
Product ID
47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207136
Marketing category
ANDA
Marketing start
2020-02-28
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
47335-171-48Tobramycin4 in 1 POUCHSOLUTION46
47335-171-48Tobramycin5 mL in 1 AMPULESOLUTION56
47335-171-49Tobramycin14 in 1 CARTONSOLUTION146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-171TOBRAMYCIN SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20230428_c452e428-0d8f-4f35-b98f-5aa3b814cb49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSNc452e428-0d8f-4f35-b98f-5aa3b814cb496
348719tobramycin 60 MG/ML Inhalation SolutionSCDc452e428-0d8f-4f35-b98f-5aa3b814cb496
348719tobramycin 300 MG per 5 ML Inhalation SolutionSYc452e428-0d8f-4f35-b98f-5aa3b814cb496
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSNf2f8bf02-57f8-4d34-937a-32411fc6bfba4
348719tobramycin 60 MG/ML Inhalation SolutionSCDf2f8bf02-57f8-4d34-937a-32411fc6bfba4
348719tobramycin 300 MG per 5 ML Inhalation SolutionSYf2f8bf02-57f8-4d34-937a-32411fc6bfba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-171-48473350171484 in 1 POUCHHistorical
47335-171-494733501714914 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE14 pouch2020-02-280000-00-00NoNoCurrent