Tobramycin

Product NDC
63187-973
11-digit product format
631870973
Labeler code
63187
Product ID
63187-973_3439b089-5661-47e1-87e9-7b18c7d61540
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Proficient Rx LP
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
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
63187-973-05Tobramycin5 mL in 1 BOTTLE, PLASTICSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-973TOBRAMYCIN SOLUTION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20191105_4eb4dfd1-f3ae-4400-b043-910b4c77296b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSN4eb4dfd1-f3ae-4400-b043-910b4c77296b3
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD4eb4dfd1-f3ae-4400-b043-910b4c77296b3
313415tobramycin 0.3 % Ophthalmic SolutionSY4eb4dfd1-f3ae-4400-b043-910b4c77296b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-973-05631870973055 mL in 1 BOTTLE, PLASTIC (63187-973-05) 5 ml2018-01-010000-00-00NoNoCurrent