FDA.reportPublic FDA data

Atovaquone and Proguanil HCl

Product NDC
66993-060
11-digit product format
669930060
Labeler code
66993
Product ID
66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-27
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250; 100 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone and Proguanil HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE250 mg/1
PROGUANIL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY883P1Z2LT, R71Y86M0WT
Rxcui864675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-060-02Atovaquone and Proguanil HCl100 in 1 BOTTLETABLET, FILM COATED10015
66993-060-27Atovaquone and Proguanil HCl24 in 1 DOSE PACKTABLET, FILM COATED2415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-060-02EA - Each66993-060b2821934-b008-4e92-9aca-88fdf75abfe112013-02-13
66993-060-27EA - Each66993-0608ee2fbff-608a-4137-8509-01bf9172b9a112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-060ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PRASCO LABORATORIES]14Current NDC, Legacy NDC, 2 package rows20240901_7069521a-c7f9-4e8d-99b8-0cb5c971e7cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN593baf3d-bd9e-4a44-8f90-125aa4a7a99e16
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD593baf3d-bd9e-4a44-8f90-125aa4a7a99e16
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN7069521a-c7f9-4e8d-99b8-0cb5c971e7cf15
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD7069521a-c7f9-4e8d-99b8-0cb5c971e7cf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-060-0266993006002100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02) 2012-07-270000-00-00NoNoCurrent
66993-060-276699300602724 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27) 2012-07-270000-00-00NoNoCurrent