NDC 43063-393

Atovaquone and Proguanil Hydrochloride

Atovaquone And Proguanil Hydrochloride

Atovaquone and Proguanil Hydrochloride 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 ID43063-393_7cc592e7-18af-64ad-e053-2a91aa0ae77b
NDC43063-393
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone and Proguanil Hydrochloride
Generic NameAtovaquone And Proguanil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA091211
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 Through2019-12-31

Packaging

NDC 43063-393-14

14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-14)
Marketing Start Date2012-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-393-14 [43063039314]

Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02

NDC 43063-393-20 [43063039320]

Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE250 mg/1

OpenFDA Data

SPL SET ID:a79fb027-66a6-47c8-9ee7-ce9367e9ec6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675
    • UPC Code
  • 0343063522073

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    68258-1104Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloride
    43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride
    0173-0675MALARONEatovaquone and proguanil hydrochloride
    0173-0676MALARONEatovaquone and proguanil hydrochloride
    50090-0687MALARONEatovaquone and proguanil hydrochloride
    50090-0688MALARONEatovaquone and proguanil hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.