NDC 43063-522

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 Pd-rx Pharmaceuticals, Inc.. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID43063-522_7fc278b2-1478-6b90-e053-2a91aa0a55b3
NDC43063-522
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 NamePD-Rx Pharmaceuticals, Inc.
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 43063-522-07

7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-07)
Marketing Start Date2015-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-522-24 [43063052224]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-73 [43063052273]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-07 [43063052207]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-69 [43063052269]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-14 [43063052214]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-20 [43063052220]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 43063-522-68 [43063052268]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE250 mg/1

OpenFDA Data

SPL SET ID:dcf43cbd-fc97-4dc1-a258-afad6cf4cabf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675
    • UPC Code
  • 0343063522141

    • Pharmacological Class

    • 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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