Tobramycin

Product NDC
70700-173
11-digit product format
707000173
Labeler code
70700
Product ID
70700-173_4b807769-4cf0-f110-e063-6294a90ac6a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xiromed LLC
Application
ANDA211189
Marketing category
ANDA
Marketing start
2021-07-12
Substance
TOBRAMYCIN SULFATE
Active strength
1.2 g/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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-173-22Tobramycin50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,5012
70700-173-22Tobramycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
70700-173-86Tobramycin50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,5012
70700-173-86Tobramycin6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-173-22EA - Each70700-1734dcc45e1-8f8e-4b5f-8df9-fb9ad1cd4be712021-07-15
70700-173-86EA - Each70700-173d973d8d6-585c-486d-9a87-6249fe9e983b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-173TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XIROMED LLC]11Current NDC, Legacy NDC, 4 package rows20230122_8b50d1b5-ea8a-5844-358a-493f1965c07f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSN8b50d1b5-ea8a-5844-358a-493f1965c07f12
597823tobramycin 40 MG/ML Injectable SolutionSCD8b50d1b5-ea8a-5844-358a-493f1965c07f12
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSY8b50d1b5-ea8a-5844-358a-493f1965c07f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-173-22707000173221 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-07-120000-00-00NoNoCurrent
70700-173-86707000173866 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-86) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2023-01-200000-00-00NoNoCurrent