FDA.reportPublic FDA data

TOBRAMYCIN

Product NDC
0409-3578
11-digit product format
004093578
Labeler code
0409
Product ID
0409-3578_d69232fd-aeae-44b9-9e43-2f2e5bd843be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOBRAMYCIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA063111
Marketing category
ANDA
Marketing start
2005-05-05
Substance
TOBRAMYCIN SULFATE
Active strength
40 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOBRAMYCIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN SULFATE40 mg/mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3578-01TOBRAMYCIN25 in 1 TRAYINJECTION, SOLUTION2522
0409-3578-11TOBRAMYCIN2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3578-01ML - Milliliter0409-3578499fe499-35e0-4d1f-976a-c0e17555ca4212012-07-24
0409-3578-11ML - Milliliter0409-3578dee434a8-0763-4b38-af60-ec5d7618a9cd12020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3578TOBRAMYCIN INJECTION, SOLUTION [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20241212_c5a005b0-7b6f-4e30-df92-9a20b1ca66a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNc5a005b0-7b6f-4e30-df92-9a20b1ca66a122
597823tobramycin 40 MG/ML Injectable SolutionSCDc5a005b0-7b6f-4e30-df92-9a20b1ca66a122
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYc5a005b0-7b6f-4e30-df92-9a20b1ca66a122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3578-010040935780125 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11) 2005-05-050000-00-00NoNoCurrent
0409-3578-11004093578112 mL in 1 VIAL, MULTI-DOSE2 mlHistorical