FDA.reportPublic FDA data

NDC 72266-163-01 - 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
72266-163
Requested NDC
72266-163-01
Package NDCs from labels
72266-163-01, 72266-163-06
Manufacturer
Fosun Pharma USA Inc
Effective date
2024-07-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Fosun Pharma USA IncFosun Pharma USA Inc2024-07-02HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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
rxcui: 597823
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
ndc (package): 72266-163-06
ndc (package): 72266-163-01
ndc (product): 72266-163
ndc11 (package): 72266016301
rxcui: 597823
spl id: 55a28671-9f6d-90be-e063-6294a90ac87c
spl set id: c4751a4f-c9c1-60c5-e053-2995a90aeba9
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.