FDA.reportPublic FDA data

Tobramycin

Product NDC
0093-4085
11-digit product format
000934085
Labeler code
0093
Product ID
0093-4085_2aeb6242-a55e-4e45-96df-f2d26616e167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091589
Marketing category
ANDA
Marketing start
2013-11-19
Substance
TOBRAMYCIN
Active strength
300 mg/5mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tobramycin
Listing expiration
2027-12-31

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
0093-4085-63Tobramycin5 mL in 1 AMPULESOLUTION511
0093-4085-63Tobramycin56 in 1 CARTONSOLUTION5611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4085-63ML - Milliliter0093-4085e5ae01b3-9864-4471-8184-79489b693d3a12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
NITROGENINACTIVE INGREDIENTN762921K75TOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4085TOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA, INC.]9Current NDC, Legacy NDC, 2 package rows20250226_c5f65e5b-c851-45da-a0e8-215d9a4e6ad3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSNc5f65e5b-c851-45da-a0e8-215d9a4e6ad311
348719tobramycin 60 MG/ML Inhalation SolutionSCDc5f65e5b-c851-45da-a0e8-215d9a4e6ad311
348719tobramycin 300 MG per 5 ML Inhalation SolutionSYc5f65e5b-c851-45da-a0e8-215d9a4e6ad311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4085-630009340856356 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE56 ampule2013-11-190000-00-00NoNoCurrent