NDC 68462-402

Atovaquone and Proguanil Hydrochloride Pediatric

Atovaquone And Proguanil Hydrochloride Pediatric

Atovaquone and Proguanil Hydrochloride Pediatric is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc.,usa. The primary component is Atovaquone; Proguanil Hydrochloride.

Product ID68462-402_53b07c6f-246b-49e7-be7b-b7baac4d76c2
NDC68462-402
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone and Proguanil Hydrochloride Pediatric
Generic NameAtovaquone And Proguanil Hydrochloride Pediatric
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA091211
Labeler NameGlenmark Pharmaceuticals Inc.,USA
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 68462-402-01

100 TABLET, FILM COATED in 1 BOTTLE (68462-402-01)
Marketing Start Date2015-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-402-30 [68462040230]

Atovaquone and Proguanil Hydrochloride Pediatric TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-08
Marketing End Date2015-04-08

NDC 68462-402-01 [68462040201]

Atovaquone and Proguanil Hydrochloride Pediatric TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-08

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE62.5 mg/1

OpenFDA Data

SPL SET ID:4b80d087-eaa7-448f-967e-344de7f16436
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864675
  • 864681
  • UPC Code
  • 0368462404010
  • Pharmacological Class

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

    Medicade Reported Pricing

    68462040201 ATOVAQUONE-PROGUANIL 62.5-25

    Pricing Unit: EA | Drug Type:

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