FDA.reportPublic FDA data

NDC 83301-0022-01 - 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
83301-0022
Requested NDC
83301-0022-01
Package NDCs from labels
83301-0022-1, 83301-0022-2, 83301-0022-01
Manufacturer
Mullan Pharmaceutical Inc. | Qilu Pharmaceutical Co., Ltd
Effective date
2026-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amikacin Sulfate - Mullan Pharmaceutical Inc. | Qilu Pharmaceutical Co., LtdMullan Pharmaceutical Inc. | Qilu Pharmaceutical Co., Ltd2026-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0022-1Amikacin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION22
83301-0022-2Amikacin Sulfate10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0022AMIKACIN SULFATE INJECTION [MULLAN PHARMACEUTICAL INC.]1Current NDC, 2 package rows20250426_840ba25a-d60c-4f0d-a084-71b0c68237df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0022-1ML - Milliliter83301-00226e07d502-a1ee-4023-a9ad-3bbb7f2c99b312026-02-05
83301-0022-2ML - Milliliter83301-0022729c72ae-6fa0-45f5-bddc-6a5a8d0991a412025-07-08

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 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicals6051c9d5-36ef-4bfa-baab-9862c94805fb2023-12-12WarningsExact identifier
unii: O40UQP6WCF
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: B22547B95K
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, SANGUINARIA CANADENSIS, BLATTA ORIENTALIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGERDeseret Biologicals, Inc.795c34c6-71c8-4c36-b441-4bca55a435752023-12-04WarningsExact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8692f851-0484-fa7d-e053-2991aa0a8e572023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8692a44d-2f50-d574-e053-2991aa0a7ee62023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron87713f93-9bd2-2fbf-e053-2995a90aaf9e2023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron86922572-6e29-fff4-e053-2991aa0abbd02023-11-15Exact identifier
unii: O40UQP6WCF
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, URANIUM NITRICUM, OZONEDeseret Biologicals, Inc.14a1f0a6-1b22-449c-b4dd-f8feb72155542023-10-26WarningsExact identifier
unii: O40UQP6WCF
Enviro Detox FormulaLAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SPINACIA, PETROLEUM, PLUMBUM METALLICUM, SULPHURICUM ACIDUM, AMMONIUM PHOSPHORICUM, ARSENICUM ALBUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, DIBROMOETHANE, KREOSOTUM, MERCURIUS VIVUS, MTBE (TERT-BUTYL METHYL ETHER), NITRICUM ACIDUM, RADIUM BROMATUMNutritional Specialties, Inc.83825312-dff8-4caa-8afa-bb1eab7397f72023-10-06WarningsExact identifier
unii: O40UQP6WCF
Acidum SulphuricumACIDUM SULPHURICUMHahnemann Laboratories, INC.038c2235-b113-963d-e063-6394a90a2b102023-08-22Exact identifier
unii: O40UQP6WCF
Fem Flora DefenseBAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.8015e1cb-9ebd-4b3e-af57-92f2754fb7902023-08-17WarningsExact identifier
unii: O40UQP6WCF
Clearlife Extra StrengthONION, AMBROSIA ARTEMISIIFOLIA WHOLE, APIS MELLIFERA, ARNICA MONTANA WHOLE, EUPHRASIA STRICTA, GRAPHITE,GALPHIMIA GLAUCA FLOWERING TOP,PULSATILLA VULGARIS WHOLE, HISTAMINE DIHYDROCHLORIDE, PINE TAR, SCHOENOCAULON OFFICINALE SEED, SULFUR, SULFURIC ACID,TELLURIUM AND THUJA OCCIDENTALIS LEAFY TWIGMediNatura Inc.088ba0ac-8ffa-4057-8286-88765c228f392023-06-05WarningsExact identifier
unii: O40UQP6WCF
Amikacin SulfateAMIKACIN SULFATEFresenius Kabi USA, LLCc0f57839-1c9b-49e5-8c7a-708e2d16495d2023-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
unii: B22547B95K
triCitrasolTRISODIUM CITRATE DIHYDRATECitra Labs LLC64e7652c-1437-43bd-8ea2-3cafab447b8c2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
PROSCENATSULFURIC ACID, LYTTA VESICATORIA, CONIUM MACULATUM FLOWERING TOP, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, NASTURTIUM OFFICINALE WHOLE, AND ONONIS SPINOSA WHOLEPEKANA Naturheilmittel GmbH1fe525a2-7ff6-4704-ab47-08552eb5ba4a2023-01-11WarningsExact identifier
unii: O40UQP6WCF
OPSONATSILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbH506f8227-207c-462c-a71c-5f8f00b4f8de2023-01-11WarningsExact identifier
unii: O40UQP6WCF
GLUCOREKTLACTIC ACID, DL-, SULFURIC ACID, ONION, CHIONANTHUS VIRGINICUS BARK, PHOSPHORUS, ZINC SULFATE HEPTAHYDRATE, CORN SILK, AND SYZYGIUM CUMINI FRUITPEKANA Naturheilmittel GmbH86293764-46a8-455a-8cba-7b4b3e1273872023-01-11WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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