NDC 63629-5531

Atovaquone and Proguanil HCl

Atovaquone And Proguanil Hydrochloride

Atovaquone and Proguanil HCl is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID63629-5531_1019466e-5b22-4819-aee7-a08e2955f7d6
NDC63629-5531
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone and Proguanil HCl
Generic NameAtovaquone And Proguanil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-07-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021078
Labeler NameBryant Ranch Prepack
Substance NameATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active Ingredient Strength250 mg/1; mg/1
Pharm ClassesAntimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63629-5531-1

10 TABLET, FILM COATED in 1 BOTTLE (63629-5531-1)
Marketing Start Date2015-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5531-4 [63629553104]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-15

NDC 63629-5531-3 [63629553103]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-21

NDC 63629-5531-2 [63629553102]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-21

NDC 63629-5531-1 [63629553101]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-21

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE250 mg/1

OpenFDA Data

SPL SET ID:7d124c6f-dbdb-48ee-8fd2-9880fdf9d765
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675

    • Pharmacological Class

    • Antimalarial [EPC]
    • Antiprotozoal [EPC]
    • Antimalarial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]
    • Antimalarial [EPC]
    • Antiprotozoal [EPC]
    • Antimalarial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "Atovaquone and Proguanil HCl" or generic name "Atovaquone And Proguanil Hydrochloride"

    NDCBrand NameGeneric Name
    43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    63629-5531Atovaquone and Proguanil HClAtovaquone and Proguanil HCl
    66993-060Atovaquone and Proguanil HClAtovaquone and Proguanil HCl
    0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloride
    0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloride
    10544-909Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    33261-900Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    42254-150Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    0173-0675MALARONEatovaquone and proguanil hydrochloride
    0173-0676MALARONEatovaquone and proguanil hydrochloride
    50090-0687MALARONEatovaquone and proguanil hydrochloride
    50090-0688MALARONEatovaquone and proguanil hydrochloride
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