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 9 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: O40UQP6WCF
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Amikacin SulfateAMIKACIN SULFATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.7791d3e1-9287-4f75-b4f0-e5d35cacfd6e2024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amikacin SulfateAMIKACIN SULFATEHikma Pharmaceuticals USA Inc.0b56f6df-a05d-4520-8bf0-d7cefe20f6ad2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA063315
ndc (package): 0641-6166-01
ndc (package): 0641-6167-10
ndc (package): 0641-6167-01
ndc (package): 0641-6166-10
ndc (product): 0641-6166
ndc (product): 0641-6167
ndc11 (package): 00641616601
rxcui: 1723156
rxcui: 1723160
spl id: 36fb925f-8beb-4691-9136-500772c736fa
spl set id: 0b56f6df-a05d-4520-8bf0-d7cefe20f6ad
unii: N6M33094FD
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: O40UQP6WCF
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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