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 2 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: O40UQP6WCF
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: O40UQP6WCF
Large Joint Pain Drops 2037LARGE JOINT PAIN DROPSProfessional Complementary Health Formulasb34b0fce-9b7a-4f64-b557-b9c0ad61187c2026-01-08WarningsExact identifier
unii: O40UQP6WCF
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: O40UQP6WCF
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: O40UQP6WCF
SlenderiixWEIGHT MANAGEMENT FORMULAVitality Works398251ec-6834-4dda-abc6-f503632d16322025-12-17WarningsExact identifier
unii: O40UQP6WCF
Amikacin SulfateAMIKACIN SULFATEQilu Pharmaceutical Co., Ltd.20fa61ef-11e2-4d01-82ea-b5412cefaead2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA218146
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
Skinade MD INsupportARNICA, LEDUM, CALENDULA, BELLIS PERENNIS, HYPERICUM PERF. SULPH.AC., THIOSINAMINUM, VIT.K1Bottled Science, Inc.eb0069b3-8f68-3f41-e053-2995a90adbac2025-10-16WarningsExact identifier
unii: O40UQP6WCF
QUALITY CHOICE Nausea ReliefSODIUM CITRATE DIHYDRATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)d89e41c1-399a-4157-8d54-bfefe3b1c1cd2025-10-01WarningsExact identifier
unii: B22547B95K
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: O40UQP6WCF
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: O40UQP6WCF
PhytogelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, RHUS TOX, SULPHURICUM ACIDUM, SYMPHYTUM OFFICINALEEnergetix Corporatione94b4f4c-bf4e-4210-a4e1-f2b7341e6dcc2025-07-15WarningsExact identifier
unii: O40UQP6WCF
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
unii: B22547B95K
MenopauseANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.03ce1f50-6af5-4640-825f-67fcb25e76e62025-06-24WarningsExact identifier
unii: O40UQP6WCF
Amikacin SulfateAMIKACIN SULFATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.a43188fa-f228-4acd-8a5d-9a3462034f4b2025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723156
rxcui: 1723160
unii: N6M33094FD
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, SANGUINARIA CANADENSIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, MEPHITIS MEPHITICADeseret Biologicals, Inc.22b6a444-68de-43a3-85e8-e8a74b3914bc2025-05-27WarningsExact identifier
unii: O40UQP6WCF
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
unii: B22547B95K
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: O40UQP6WCF
Bestmade Natural Products BM191KREOSOTUM, NITRIC ACID, SULPHUR, SULPHURIC ACID, URTICA URENBestmade Natural Products2ea7c2e5-73d6-6820-e063-6294a90aaf1c2025-02-21WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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