FDA.reportPublic FDA data

NDC 0641-6166-01 - Amikacin Sulfate

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
0641-6166
Requested NDC
0641-6166-01
Package NDCs from labels
0641-6166-01, 0641-6166-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMIKACIN SULFATE INJECTION, USPHikma Pharmaceuticals USA Inc.2024-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6166-01Amikacin Sulfate4 mL in 1 VIALINJECTION410
0641-6166-10Amikacin Sulfate10 in 1 CARTONINJECTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6166AMIKACIN SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240410_0b56f6df-a05d-4520-8bf0-d7cefe20f6ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6166-01ML - Milliliter0641-61663cfe97bf-23bc-48b5-82f2-8afece928a1612016-01-13
0641-6166-10ML - Milliliter0641-61663b98a712-a6ff-48bd-bc4f-95d6ae0cc65a12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIKACIN SULFATEACTIVE INGREDIENTN6M33094FDAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
AMIKACINACTIVE MOIETY84319SGC3CAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM CITRATE, UNSPECIFIED FORMINACTIVE INGREDIENT1Q73Q2JULRAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3

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 14 · 265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
amikacin sulfateAMIKACIN SULFATESagent Pharmaceuticalsf260ff2a-76a0-4672-9516-91c344b678902026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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