FDA.reportPublic FDA data

Tobrex

Product NDC
21695-458
11-digit product format
216950458
Labeler code
21695
Product ID
21695-458_3d4be22b-7a8c-4247-ac35-143611342de1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
NDA050555
Marketing category
NDA
Marketing start
1981-11-25
Marketing end
0000-00-00
Substance
TOBRAMYCIN
Active strength
3 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-458-352019-09-24C16284748780-1934fe258-4a76-48b1-e053-8cdaa90a720aTobrex tobramycin ophthalmic ointment 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-458-35Tobrex3.5 g in 1 TUBEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-458-35GM - Gram21695-458018facd8-9178-41b4-98ff-8ca67e07f6de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tobramycinACTIVE INGREDIENTVZ8RRZ51VKTOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1
tobramycinACTIVE MOIETYVZ8RRZ51VKTOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCTOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-458TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_3d4be22b-7a8c-4247-ac35-143611342de1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313414tobramycin 0.3 % Ophthalmic OintmentPSN3d4be22b-7a8c-4247-ac35-143611342de11
207850Tobrex 0.3 % Ophthalmic OintmentPSN3d4be22b-7a8c-4247-ac35-143611342de11
207850tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex]SBD3d4be22b-7a8c-4247-ac35-143611342de11
313414tobramycin 0.003 MG/MG Ophthalmic OintmentSCD3d4be22b-7a8c-4247-ac35-143611342de11
313414tobramycin 0.3 % Ophthalmic OintmentSY3d4be22b-7a8c-4247-ac35-143611342de11
207850Tobrex 0.003 MG/MG Ophthalmic OintmentSY3d4be22b-7a8c-4247-ac35-143611342de11
207850Tobrex 0.3 % Ophthalmic OintmentSY3d4be22b-7a8c-4247-ac35-143611342de11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-458-35216950458353.5 g in 1 TUBE3.5 gHistorical