Tobramycin

Product NDC
72266-163
11-digit product format
722660163
Labeler code
72266
Product ID
72266-163_1c499644-6570-e991-e063-6394a90a7b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc
Application
ANDA211189
Marketing category
ANDA
Marketing start
2021-08-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-163-01Tobramycin30 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,303
72266-163-06Tobramycin6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-163-01EA - Each72266-163aa2e13c0-f672-46f0-9998-66a5b05280a912021-09-07
72266-163-06EA - Each72266-163cd53756c-fed9-441a-8287-c308f897002612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-163TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]3Current NDC, Legacy NDC, 2 package rows20240704_c4751a4f-c9c1-60c5-e053-2995a90aeba9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNc4751a4f-c9c1-60c5-e053-2995a90aeba93
597823tobramycin 40 MG/ML Injectable SolutionSCDc4751a4f-c9c1-60c5-e053-2995a90aeba93
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYc4751a4f-c9c1-60c5-e053-2995a90aeba93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-163-017226601630130 mL in 1 VIAL, PHARMACY BULK PACKAGE30 mlHistorical
72266-163-06722660163066 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72266-163-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (72266-163-01) 2021-08-110000-00-00NoNoCurrent