FDA.reportPublic FDA data

NDC 0904-7459-41 - 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
0904-7459
Requested NDC
0904-7459-41
Package NDCs from labels
0904-7459-41, 0904-7459-25, 0904-7459-53
Manufacturer
Major Pharmaceuticals | PAI Holdings, LLC
Effective date
2025-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atovaquone Oral Suspension - Major Pharmaceuticals | PAI Holdings, LLCMajor Pharmaceuticals | PAI Holdings, LLC2025-08-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7459-25ATOVAQUONE3 in 1 CASESUSPENSION36
0904-7459-25ATOVAQUONE6 in 1 TRAYSUSPENSION66
0904-7459-41ATOVAQUONE5 mL in 1 CUP, UNIT-DOSESUSPENSION56
0904-7459-53ATOVAQUONE7 in 1 CASESUSPENSION76
0904-7459-53ATOVAQUONE6 in 1 TRAYSUSPENSION66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7459ATOVAQUONE (ATOVAQUONE ORAL SUSPENSION) SUSPENSION [MAJOR PHARMACEUTICALS]5Current NDC, 5 package rows20241116_73e2297e-7cda-4abf-9fb7-8c67cb5638a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7459-25ML - Milliliter0904-7459593f95c2-5004-44ef-9ead-02432803e8c412024-08-12
0904-7459-41ML - Milliliter0904-7459a8303416-8bfe-4411-868f-28ca0acfdbe712024-08-12
0904-7459-53ML - Milliliter0904-7459cdb1a6e3-092b-4201-9536-db8e93570a3e12024-08-12

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 11 · 218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
rxcui: 308429
unii: Y883P1Z2LT
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.40331de7-819e-5965-e063-6294a90ac91d2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AtovaquoneATOVAQUONEKesin Pharma16b69156-e5de-c601-e063-6394a90afeae2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 308429
unii: Y883P1Z2LT
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ATOVAQUONEATOVAQUONE ORAL SUSPENSIONMajor Pharmaceuticals73e2297e-7cda-4abf-9fb7-8c67cb5638a32025-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA214272
ndc (package): 0904-7459-25
ndc (package): 0904-7459-53
ndc (package): 0904-7459-41
ndc (product): 0904-7459
ndc11 (package): 00904745941
rxcui: 308429
spl id: 9c1dfc30-52ac-4fec-a728-135917f39c1a
spl set id: 73e2297e-7cda-4abf-9fb7-8c67cb5638a3
unii: Y883P1Z2LT

Reported adverse events (FAERS/openFDA)#

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