FDA.reportPublic FDA data

NDC 72603-160-01 - Tobramycin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72603-160
Requested NDC
72603-160-01
Package NDCs from labels
72603-160-01, 72603-160-06
Manufacturer
Northstar Rx LLC | GLAND PHARMA LIMITED
Effective date
2025-09-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Northstar Rx LLC | GLAND PHARMA LIMITEDNorthstar Rx LLC | GLAND PHARMA LIMITED2025-09-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-160-01Tobramycin50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,503
72603-160-06Tobramycin6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-160TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC]2Current NDC, 2 package rows20240402_55d09ffd-4f32-8aeb-3904-8a17db635e3a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-160-01EA - Each72603-160ea10166e-164f-4d70-81a1-3e40f92618ad12025-10-14
72603-160-06EA - Each72603-1603d61670f-5a5c-4c68-bbed-fdae6f9c6b6c12024-05-16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCINTOBRAMYCINHospira, Inc.c5a005b0-7b6f-4e30-df92-9a20b1ca66a12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINXiromed LLC8b50d1b5-ea8a-5844-358a-493f1965c07f2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211189
rxcui: 597823
unii: HJT0RXD7JK
tobramycinTOBRAMYCINSlate Run Pharmaceuticals, LLCed254eec-10f4-425a-895b-66e325b7bf692026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
TobramycinTOBRAMYCINXGen Pharmaceuticals DJB, Inc.a384641c-04e3-4ab5-b152-7408cd07b64d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINNorthstar Rx LLC55d09ffd-4f32-8aeb-3904-8a17db635e3a2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211189
ndc (package): 72603-160-01
ndc (package): 72603-160-06
ndc (product): 72603-160
ndc11 (package): 72603016001
rxcui: 597823
spl id: 3f7a227f-2fe6-52d8-e063-6294a90a2838
spl set id: 55d09ffd-4f32-8aeb-3904-8a17db635e3a
unii: HJT0RXD7JK
TOBRAMYCINTOBRAMYCINEugia US LLCc37c251f-92e9-40f0-8b0c-00d42875d7762024-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLC9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd6dd9460-b030-479a-b3e3-03606e6fcad12024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCIN SULFATEFresenius Kabi USA, LLCd62ff359-912b-4be1-9fc2-2dde8777eefb2024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINBaxter Healthcare Corporationa9897444-71f6-42af-9b71-4aa77829ade02023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINGland Pharma Limited645d34d9-275d-428e-863d-ae15ad009c442023-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINGland Pharma Limited02b48684-168c-4cd9-8375-794206eff23e2023-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINFosun Pharma USA Incc4751a4f-c9c1-60c5-e053-2995a90aeba92022-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211189
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINMylan Institutional LLCac8134d9-a726-4508-b8b9-a536ef17243d2022-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 597823
unii: HJT0RXD7JK
TobramycinTOBRAMYCINGland Pharma Limited38219f34-4859-428f-9ec1-06ead76042112022-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211189
rxcui: 597823
unii: HJT0RXD7JK

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.