Atovaquone and Proguanil Hydrochloride

Product NDC
42254-150
11-digit product format
422540150
Labeler code
42254
Product ID
42254-150_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone and Proguanil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA091211
Marketing category
ANDA
Marketing start
2011-08-18
Marketing end
0000-00-00
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
42254-150-162019-09-24C16284748780-19350213a-3c1a-c013-e053-90daa90a1393Atovaquone and Proguanil Hydrochloride Tablets
42254-150-242019-09-24C16284748780-19350213a-3c1a-c013-e053-90daa90a1393Atovaquone and Proguanil Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-150-16Atovaquone and Proguanil Hydrochloride16 in 1 BOTTLETABLET161
42254-150-24Atovaquone and Proguanil Hydrochloride24 in 1 BOTTLETABLET241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-150-16EA - Each42254-1500527feec-7883-4e12-bb5e-b14bd2dfe48312012-07-24
42254-150-24EA - Each42254-1508c2fcefc-634e-4cab-a48c-80387c6363e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-150ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120308_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-150-164225401501616 in 1 BOTTLEHistorical
42254-150-244225401502424 in 1 BOTTLEHistorical