FDA.reportPublic FDA data

TOBRAMYCIN

Product NDC
55150-470
11-digit product format
551500470
Labeler code
55150
Product ID
55150-470_a4205ba6-2eba-4e4e-a2d4-b54447ed85f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOBRAMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA217519
Marketing category
ANDA
Marketing start
2023-06-21
Substance
TOBRAMYCIN SULFATE
Active strength
1.2 g/30mL
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
TOBRAMYCIN SULFATE1.2 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHJT0RXD7JK
Rxcui597823

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
55150-470-062024-01-30C16284748780-11030e365-365b-111a-e063-dadaa90a10e2Tobramycin for Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-470-01TOBRAMYCIN30 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,302
55150-470-06TOBRAMYCIN6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-470-01EA - Each55150-4700481f10c-cec1-4353-b422-90422538c88412023-08-08
55150-470-06EA - Each55150-470825dfc87-2e8a-46a0-8b88-ca9bab06eb0012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-470TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]2Current NDC, 2 package rows20240709_c37c251f-92e9-40f0-8b0c-00d42875d776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNc37c251f-92e9-40f0-8b0c-00d42875d7762
597823tobramycin 40 MG/ML Injectable SolutionSCDc37c251f-92e9-40f0-8b0c-00d42875d7762
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYc37c251f-92e9-40f0-8b0c-00d42875d7762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-470-015515004700130 mL in 1 VIAL, PHARMACY BULK PACKAGE30 mlHistorical
55150-470-06551500470066 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-470-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (55150-470-01) 2023-06-21NoNoHistorical