NDC 50090-2980

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 A-s Medication Solutions. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID50090-2980_00a50302-23ca-475a-93c1-b0e744e69b58
NDC50090-2980
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 NameA-S Medication Solutions
Substance NameATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active Ingredient Strength250 mg/1; mg/1
Pharm ClassesAntimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50090-2980-0

7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)
Marketing Start Date2017-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-2980-6 [50090298006]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-16

NDC 50090-2980-2 [50090298002]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-08

NDC 50090-2980-1 [50090298001]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-27

NDC 50090-2980-7 [50090298007]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-17

NDC 50090-2980-0 [50090298000]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-04

NDC 50090-2980-8 [50090298008]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-01

NDC 50090-2980-5 [50090298005]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-25

NDC 50090-2980-3 [50090298003]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-28

NDC 50090-2980-9 [50090298009]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-12

NDC 50090-2980-4 [50090298004]

Atovaquone and Proguanil HCl TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-21

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE250 mg/1

OpenFDA Data

SPL SET ID:593baf3d-bd9e-4a44-8f90-125aa4a7a99e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675

    • 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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