FDA.reportPublic FDA data

Atovaquone

Product NDC
0121-1016
11-digit product format
001211016
Labeler code
0121
Product ID
0121-1016_0145c97d-2d5e-4fcd-ae76-85e4ae946350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA214272
Marketing category
ANDA
Marketing start
2024-01-10
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE750 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY883P1Z2LT
Rxcui308429

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1016-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION513
0121-1016-18Atovaquone6 in 1 TRAYSUSPENSION613
0121-1016-18Atovaquone3 in 1 CASESUSPENSION313
0121-1016-42Atovaquone6 in 1 TRAYSUSPENSION613
0121-1016-42Atovaquone7 in 1 CASESUSPENSION713
0121-1016-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION54
0121-1016-18Atovaquone3 in 1 CASESUSPENSION34
0121-1016-18Atovaquone6 in 1 TRAYSUSPENSION64
0121-1016-42Atovaquone7 in 1 CASESUSPENSION74
0121-1016-42Atovaquone6 in 1 TRAYSUSPENSION64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1016-05ML - Milliliter0121-10169865d66d-14b0-4346-aaaa-e329fddf195512024-02-14
0121-1016-18ML - Milliliter0121-10167b463db3-7c8c-455a-b126-c94f66f19ef112024-02-14
0121-1016-42ML - Milliliter0121-101639aab3ee-2ada-4bbf-8ca2-59a453d4fdf812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1016ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC]2Current NDC, 5 package rows20240215_2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 150 MG/ML Oral SuspensionSCDdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 750 MG per 5 ML Oral SuspensionSYdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be4
308429atovaquone 150 MG/ML Oral SuspensionSCD2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be4
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be4
308429atovaquone 750 MG per 5 ML Oral SuspensionSY2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1016-05001211016055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-1016-18001211016183 TRAY in 1 CASE (0121-1016-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05) 3 tray2024-01-10NoNoCurrent
0121-1016-42001211016427 TRAY in 1 CASE (0121-1016-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05) 7 tray2024-01-10NoNoCurrent