FDA.reportPublic FDA data

NDC 50268-119-11 - 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
50268-119
Requested NDC
50268-119-11
Package NDCs from labels
50268-119-11, 50268-119-12
Manufacturer
AvPAK
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ATOVAQUONE - AvPAKAvPAK2025-10-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-119-11ATOVAQUONE5 mL in 1 CUPSUSPENSION51
50268-119-12ATOVAQUONE20 in 1 BOXSUSPENSION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-119-11ML - Milliliter50268-1191bed614c-3461-4abf-9e29-610433df95e512025-12-16
50268-119-12ML - Milliliter50268-1191936f681-2022-4c54-b7a4-10e28aa0e27212025-12-16

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 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-09-03Warnings, Adverse reactionsExact identifier
unii: Y883P1Z2LT
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBryant Ranch Prepacke4ff57f7-07af-4872-ac3a-c521e098ccfe2026-07-27Warnings, Adverse reactionsExact identifier
unii: Y883P1Z2LT
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
application number: ANDA202960
rxcui: 308429
unii: Y883P1Z2LT
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
atovaquoneATOVAQUONEGlenmark Pharmaceuticals Inc., USA9045ba6f-938e-4717-bfa2-a3efe52f04cd2026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
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
application number: ANDA202960
ndc (product): 65162-693
rxcui: 308429
spl id: ea283214-c6a9-42be-a5fe-b35a74aa56af
spl set id: b7398fcf-522a-488a-8dd6-051561f62804
unii: Y883P1Z2LT
Atovaquone and Proguanil Hydrochloride PediatricATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRICGlenmark Pharmaceuticals Inc.,USA4b80d087-eaa7-448f-967e-344de7f164362026-04-24Warnings, Adverse reactionsExact identifier
unii: Y883P1Z2LT
MEPRONATOVAQUONEGlaxoSmithKline LLCb426b6bf-f07e-4580-97ae-dfca1ddf5b8f2026-03-20Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
Atovaquone Oral SuspensionATOVAQUONEKesin Pharma Corporation4a2e2c4b-85aa-9b30-e063-6294a90a7bd92026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEGolden State Medical Supply, Inc.ddbfe1a9-df9b-79b0-e053-2995a90acc9b2025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEGolden State Medical Supply, Inc.152433eb-1341-9cc0-e063-6394a90a14812025-12-11Warnings, Adverse reactionsExact identifier
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEBionpharma Inc.bff4f4fc-6307-f414-e053-2a95a90ac0de2025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEChartwell Governmental & Specialty RX, LLC.e6770b85-54f8-4969-af02-7d81586be7612025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEAmerican Health Packaging1a8a43a2-bc26-4ee5-aa35-22a5477a71292025-10-17Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
ATOVAQUONEATOVAQUONEAvPAK4124ad97-f6b9-8afb-e063-6294a90ab9702025-10-14Warnings, Adverse reactionsExact identifier
application number: ANDA202960
ndc (package): 50268-119-11
ndc (package): 50268-119-12
ndc (product): 50268-119
ndc11 (package): 50268011911
rxcui: 308429
spl id: 4124a674-5e02-72c3-e063-6294a90ad785
spl set id: 4124ad97-f6b9-8afb-e063-6294a90ab970
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.40331de7-819e-5965-e063-6294a90ac91d2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEKesin Pharma16b69156-e5de-c601-e063-6394a90afeae2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT

Reported adverse events (FAERS/openFDA)#

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