FDA.reportPublic FDA data

NDC 39822-0412-01 - 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
39822-0412
Requested NDC
39822-0412-01
Package NDCs from labels
39822-0412-6, 39822-0412-1, 39822-0412-01
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Effective date
2025-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin for Injection USP, 1.2 gmXGen Pharmaceuticals DJB, Inc.2025-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0412-1Tobramycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,127
39822-0412-1Tobramycin30 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3027
39822-0412-6Tobramycin6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,627
39822-0412-6Tobramycin30 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0412TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]26Current NDC, Legacy NDC, 4 package rows20230328_a384641c-04e3-4ab5-b152-7408cd07b64d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0412-1EA - Each39822-04123f999960-0cf0-4181-b285-b2112146976a12012-07-24
39822-0412-6EA - Each39822-041276dcde81-f11f-4a94-b41b-7aa8c6a72a2912013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]16
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]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
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
application number: ANDA065013
ndc (package): 39822-0412-1
ndc (package): 39822-0412-6
ndc (product): 39822-0412
ndc11 (package): 39822041201
rxcui: 597823
spl id: 40a90656-9bc2-494b-e063-6294a90a04f2
spl set id: a384641c-04e3-4ab5-b152-7408cd07b64d
unii: HJT0RXD7JK
TobramycinTOBRAMYCINNorthstar Rx LLC55d09ffd-4f32-8aeb-3904-8a17db635e3a2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
rxcui: 597823
unii: HJT0RXD7JK

Reported adverse events (FAERS/openFDA)#

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