FDA.reportPublic FDA data

tobramycin

Product NDC
70436-110
11-digit product format
704360110
Labeler code
70436
Product ID
70436-110_4a830833-6027-9c0a-e063-6394a90a27ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217029
Marketing category
ANDA
Marketing start
2023-02-01
Substance
TOBRAMYCIN
Active strength
1200 mg/30mL
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
TOBRAMYCIN1200 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
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
70436-110-36tobramycin30 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION304
70436-110-56tobramycin180 mL in 1 CARTONINJECTION, POWDER, FOR SOLUTION1804
70436-110-80tobramycin30 mL in 1 CARTONINJECTION, POWDER, FOR SOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-110TOBRAMYCIN INJECTION, POWDER, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20231109_ed254eec-10f4-425a-895b-66e325b7bf69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNed254eec-10f4-425a-895b-66e325b7bf694
597823tobramycin 40 MG/ML Injectable SolutionSCDed254eec-10f4-425a-895b-66e325b7bf694
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYed254eec-10f4-425a-895b-66e325b7bf694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-110-367043601103630 mL in 1 VIAL (70436-110-36) 30 ml2023-02-01NoNoCurrent
70436-110-5670436011056180 mL in 1 CARTON (70436-110-56) 180 ml2023-02-01NoNoCurrent
70436-110-807043601108030 mL in 1 CARTON (70436-110-80) 30 ml2023-12-01NoNoCurrent