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 5 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemDetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUMDr. Donna Restivo DC2a17f80d-12c0-43a0-980b-9da648e9b76a2023-01-10WarningsExact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8693236a-a8ab-2f7f-e053-2991aa0a11962023-01-05Exact identifier
unii: O40UQP6WCF
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: O40UQP6WCF
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.14b238ab-904b-45dc-9eb9-a1074364e0892022-11-07Exact identifier
unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: B22547B95K
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: B22547B95K
Bruise RXERIGERON CANADENSIS, HAMAMELIS VIRGINIANA, PHOSPHORUS, SULPHURICUM ACIDUM, ARNICA MONTANA, LEDUM PALUSTRE, BELLIS PERENNISRemedies Cure, LLC8fbac9c7-45ac-4a9b-bdff-6f19d238a6012022-08-10WarningsExact identifier
unii: O40UQP6WCF
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.a63da38d-1fea-4ee0-a70b-55c891a5ebcc2022-02-11Exact identifier
unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.ac8971a9-36d0-43c9-9121-ba5e58c28bed2022-02-11Exact identifier
unii: B22547B95K
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: O40UQP6WCF
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: B22547B95K
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: B22547B95K
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: B22547B95K
SEPIA PLEXACONITUM NAPELLUS, CIMICIFUGA RACEMOSA, LACHESIS MUTUS, MELISSA OFFICINALIS, PLATINUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA, SULPHURICUM ACIDUM, VALERIANA OFFICINALISSeroyal USA4c4a0a95-3848-4e19-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: O40UQP6WCF
Visceral PolarityACONITUM NAP, ARG NIT, CHININUM PUR, ECHINACEA PURP, PLUM MET, SEPIA, SULPHURICUM ACNET Remedies971e74ea-f72f-403e-bc79-02901e5019e82021-01-21WarningsExact identifier
unii: O40UQP6WCF
FungalCANDIDA 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.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: O40UQP6WCF
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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