FDA.reportPublic FDA data

NDC 81033-104-05 - Atovaquone

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
81033-104
Requested NDC
81033-104-05
Package NDCs from labels
81033-104-05, 81033-104-50, 81033-104-42, 81033-104-22
Manufacturer
Kesin Pharma
Effective date
2025-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atovaquone - Kesin PharmaKesin Pharma2025-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-104-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION55
81033-104-22Atovaquone20 in 1 CARTONSUSPENSION205
81033-104-42Atovaquone42 in 1 CARTONSUSPENSION425
81033-104-50Atovaquone50 in 1 CARTONSUSPENSION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-104ATOVAQUONE SUSPENSION [KESIN PHARMA]4Current NDC, 4 package rows20241207_16b69156-e5de-c601-e063-6394a90afeae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-104-05ML - Milliliter81033-104c018edbe-f696-48dc-892d-d7f7065758a712024-10-04
81033-104-22ML - Milliliter81033-1041ef5ddc5-193e-4226-885e-1840aee1234e12025-10-14
81033-104-42ML - Milliliter81033-1044c08e487-0466-489b-bf78-671ea706112b12024-10-04

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 13 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Atovaquone Oral SuspensionATOVAQUONEKVK-Tech, Inc.b31ff20a-c363-4be0-9bc0-3081c163b63c2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
ATOVAQUONEATOVAQUONEAvKARE54423fee-da60-25dc-e063-6294a90a25522026-06-14Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
AtovaquoneATOVAQUONECamber Pharmaceuticals, Inc.2445304e-4b4e-4358-b098-31f3c49c52ef2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
MALARONEATOVAQUONE AND PROGUANIL HYDROCHLORIDEGlaxoSmithKline LLCfc22e8d8-3bfb-4f70-a599-dd81262a48872026-06-10Warnings, Adverse reactionsExact identifier
unii: Y883P1Z2LT
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
atovaquoneATOVAQUONEGlenmark Pharmaceuticals Inc., USA9045ba6f-938e-4717-bfa2-a3efe52f04cd2026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
AtovaquoneATOVAQUONEPAI Holdings, LLC dba PAI Pharmadf6086d3-6100-422a-bf23-e9610027749b2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCb7398fcf-522a-488a-8dd6-051561f628042026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT

Reported adverse events (FAERS/openFDA)#

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