FDA.reportPublic FDA data

Tobramycin

Product NDC
72603-630
11-digit product format
726030630
Labeler code
72603
Product ID
72603-630_9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NorthStar RxLLC
Application
ANDA216725
Marketing category
ANDA
Marketing start
2024-08-01
Substance
TOBRAMYCIN
Active strength
300 mg/4mL
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
TOBRAMYCIN300 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui1314763

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
72603-630-04Tobramycin4 in 1 POUCHSOLUTION41
72603-630-04Tobramycin4 mL in 1 AMPULESOLUTION41
72603-630-56Tobramycin14 in 1 CARTONSOLUTION141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-630-04ML - Milliliter72603-63049427f0d-c08e-4fbe-b257-7ee35503afd812024-10-04
72603-630-56ML - Milliliter72603-6304a768bad-50cd-4bc7-80d4-9ad54e48d88112024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-630TOBRAMYCIN SOLUTION [NORTHSTAR RXLLC]1Current NDC, 3 package rows20240802_634efd82-1a35-40cf-9893-50c27d661083.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1314763tobramycin 300 MG in 4 ML Inhalation SolutionPSN634efd82-1a35-40cf-9893-50c27d6610831
1314763tobramycin 75 MG/ML Inhalation SolutionSCD634efd82-1a35-40cf-9893-50c27d6610831
1314763tobramycin 300 MG per 4 ML Inhalation SolutionSY634efd82-1a35-40cf-9893-50c27d6610831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-630-04726030630044 in 1 POUCHHistorical
72603-630-567260306305614 POUCH in 1 CARTON (72603-630-56) / 4 AMPULE in 1 POUCH (72603-630-04) / 4 mL in 1 AMPULE14 pouch2024-08-01NoNoHistorical