FDA.reportPublic FDA data

Tobramycin

Product NDC
63187-024
11-digit product format
631870024
Labeler code
63187
Product ID
63187-024_6458f461-e408-4dcc-b7c3-f8fb9fbcb31d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA064052
Marketing category
ANDA
Marketing start
1993-11-29
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
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
63187-024-05Tobramycin1 in 1 CARTONSOLUTION14
63187-024-05Tobramycin5 mL in 1 BOTTLE, DROPPERSOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-024-05ML - Milliliter63187-024b133b15b-0a41-47e4-b8d1-8429f9798a1c12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4TOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-024TOBRAMYCIN SOLUTION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20220716_d8235017-cb52-44d4-a6e6-6ee3f00c47d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSNd8235017-cb52-44d4-a6e6-6ee3f00c47d24
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDd8235017-cb52-44d4-a6e6-6ee3f00c47d24
313415tobramycin 0.3 % Ophthalmic SolutionSYd8235017-cb52-44d4-a6e6-6ee3f00c47d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-024-05631870024051 BOTTLE, DROPPER in 1 CARTON (63187-024-05) / 5 mL in 1 BOTTLE, DROPPER2018-11-010000-00-00NoNoCurrent