FDA.reportPublic FDA data

Tobramycin

Product NDC
61314-643
11-digit product format
613140643
Labeler code
61314
Product ID
61314-643_505c82ff-86c3-4269-96cb-faae872c7539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA062535
Marketing category
ANDA
Marketing start
1995-01-09
Substance
TOBRAMYCIN
Active strength
3 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
TOBRAMYCIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui313415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-643-05Tobramycin5 mL in 1 BOTTLE, PLASTICSOLUTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-643-05ML - Milliliter61314-643ad46b3e1-9505-4f45-b1e6-ed32d0b6866412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN SOLUTION [SANDOZ INC.]3
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN SOLUTION [SANDOZ INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN SOLUTION [SANDOZ INC.]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4TOBRAMYCIN SOLUTION [SANDOZ INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN SOLUTION [SANDOZ INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN SOLUTION [SANDOZ INC.]3
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN SOLUTION [SANDOZ INC.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN SOLUTION [SANDOZ INC.]3
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN SOLUTION [SANDOZ INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN SOLUTION [SANDOZ INC.]3
tobramycinACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
tobramycinACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
boric acidINACTIVE INGREDIENTR57ZHV85D4TOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium sulfateINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-643TOBRAMYCIN SOLUTION [SANDOZ INC]8Current NDC, Legacy NDC, 1 package rows20220205_27e2c16e-19b0-4745-93eb-5cf99f94bb92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSN27e2c16e-19b0-4745-93eb-5cf99f94bb928
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD27e2c16e-19b0-4745-93eb-5cf99f94bb928
313415tobramycin 0.3 % Ophthalmic SolutionSY27e2c16e-19b0-4745-93eb-5cf99f94bb928
313415tobramycin 0.3 % Ophthalmic SolutionPSN3a8dc8f9-3c93-4362-892e-72f6df9527f95
313415tobramycin 0.3 % Ophthalmic SolutionPSN612c3958-bb10-4fc9-8506-6533798fc8cb5
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD3a8dc8f9-3c93-4362-892e-72f6df9527f95
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD612c3958-bb10-4fc9-8506-6533798fc8cb5
313415tobramycin 0.3 % Ophthalmic SolutionSY3a8dc8f9-3c93-4362-892e-72f6df9527f95
313415tobramycin 0.3 % Ophthalmic SolutionSY612c3958-bb10-4fc9-8506-6533798fc8cb5
313415tobramycin 0.3 % Ophthalmic SolutionPSN4eb4dfd1-f3ae-4400-b043-910b4c77296b3
313415tobramycin 0.3 % Ophthalmic SolutionPSN87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD4eb4dfd1-f3ae-4400-b043-910b4c77296b3
313415tobramycin 0.3 % Ophthalmic SolutionSY87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 0.3 % Ophthalmic SolutionSY4eb4dfd1-f3ae-4400-b043-910b4c77296b3
313415tobramycin 0.3 % Ophthalmic SolutionPSNf54c1882-ca08-47f3-9c02-93551f39905e1
313415tobramycin 0.3 % Ophthalmic SolutionPSN7203ebe3-1654-9273-e053-2995a90a04c51
313415tobramycin 0.3 % Ophthalmic SolutionPSN1bc42198-c742-1193-e063-6294a90ab9301
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD7203ebe3-1654-9273-e053-2995a90a04c51
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD1bc42198-c742-1193-e063-6294a90ab9301
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDf54c1882-ca08-47f3-9c02-93551f39905e1
313415tobramycin 0.3 % Ophthalmic SolutionSY7203ebe3-1654-9273-e053-2995a90a04c51
313415tobramycin 0.3 % Ophthalmic SolutionSYf54c1882-ca08-47f3-9c02-93551f39905e1
313415tobramycin 0.3 % Ophthalmic SolutionSY1bc42198-c742-1193-e063-6294a90ab9301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-643-05613140643055 mL in 1 BOTTLE, PLASTIC (61314-643-05) 5 ml1995-01-090000-00-00NoNoCurrent