FDA.reportPublic FDA data

Amikacin Sulfate

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2013-10-31
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:49

Label at a glance#

ProductAmikacin Sulfate
Active ingredientAMIKACIN SULFATE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1d8d349-40e8-4ab6-9f36-aa84681732edProduct name320250124
7a2acf42-1a2f-4e31-9d74-f6d541e9bb46Product name120190111
37302fde-6a8c-4412-a7e0-b0fdb78cc567Product name120151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-7003-8Amikacin Sulfate1000 g in 1 BOTTLEPOWDER10001
58597-7003-9Amikacin Sulfate5000 g in 1 BOTTLEPOWDER50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-7003AMIKACIN SULFATE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]12 package rows20131031_5efe8d50-3138-43b4-bdb0-2d8a66fcdc96.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMIKACIN SULFATEACTIVE INGREDIENTN6M33094FD1
AMIKACINACTIVE MOIETY84319SGC3C1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-700358597-7003-8, 58597-7003-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMIKACIN SULFATEN6M33094FDACTIM

Source Document#

Source XML

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amikacin sulfateAMIKACIN SULFATESagent Pharmaceuticalsf260ff2a-76a0-4672-9516-91c344b678902026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: amikacin sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEMullan Pharmaceutical Inc.840ba25a-d60c-4f0d-a084-71b0c68237df2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEQilu Pharmaceutical Co., Ltd.20fa61ef-11e2-4d01-82ea-b5412cefaead2025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.a43188fa-f228-4acd-8a5d-9a3462034f4b2025-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.7791d3e1-9287-4f75-b4f0-e5d35cacfd6e2024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEHikma Pharmaceuticals USA Inc.0b56f6df-a05d-4520-8bf0-d7cefe20f6ad2024-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE
Amikacin SulfateAMIKACIN SULFATEFresenius Kabi USA, LLCc0f57839-1c9b-49e5-8c7a-708e2d16495d2023-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amikacin Sulfate
generic name: AMIKACIN SULFATE

Reported adverse events (FAERS/openFDA)#

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