FDA.reportPublic FDA data

Atovaquone and Proguanil HCl

Product NDC
63629-5531
11-digit product format
636295531
Labeler code
63629
Product ID
63629-5531_42154701-f14c-4b9e-84f4-c6152c56b3ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-27
Marketing end
0000-00-00
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5531-12024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-22024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-32024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-42024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5531-1Atovaquone and Proguanil HCl10 in 1 BOTTLETABLET, FILM COATED101007
63629-5531-2Atovaquone and Proguanil HCl24 in 1 BOTTLETABLET, FILM COATED241007
63629-5531-3Atovaquone and Proguanil HCl5 in 1 BOTTLETABLET, FILM COATED51007
63629-5531-4Atovaquone and Proguanil HCl12 in 1 BOTTLETABLET, FILM COATED121007

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5531ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1007Legacy NDC, 4 package rows20220702_7d124c6f-dbdb-48ee-8fd2-9880fdf9d765.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5531-16362955310110 TABLET, FILM COATED in 1 BOTTLE (63629-5531-1) 2015-01-210000-00-00NoNoCurrent
63629-5531-26362955310224 TABLET, FILM COATED in 1 BOTTLE (63629-5531-2) 2015-01-210000-00-00NoNoCurrent
63629-5531-3636295531035 TABLET, FILM COATED in 1 BOTTLE (63629-5531-3) 2015-01-210000-00-00NoNoCurrent
63629-5531-46362955310412 TABLET, FILM COATED in 1 BOTTLE (63629-5531-4) 2013-11-150000-00-00NoNoCurrent