NDC 0378-4160

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 Mylan Pharmaceuticals Inc.. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID0378-4160_2377f31b-0680-4376-b910-30adc71c62c5
NDC0378-4160
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone and Proguanil Hydrochloride
Generic NameAtovaquone And Proguanil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA202362
Labeler NameMylan Pharmaceuticals Inc.
Substance NameATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active Ingredient Strength63 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 0378-4160-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)
Marketing Start Date2014-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4160-01 [00378416001]

Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202362
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 0378-4160-05 [00378416005]

Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202362
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-28
Marketing End Date2017-11-28

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE62.5 mg/1

OpenFDA Data

SPL SET ID:57d74d71-8cf8-4b10-9420-22954fae623c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675
  • 864681
    • UPC Code
  • 0303784160015
  • 0303784162019

    • 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
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