NDC 66689-062

Atovaquone

Atovaquone

Atovaquone is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Vistapharm, Inc.. The primary component is Atovaquone.

Product ID66689-062_36d19063-728c-4bfa-b5aa-aead09c8d6ae
NDC66689-062
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone
Generic NameAtovaquone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA202960
Labeler NameVistaPharm, Inc.
Substance NameATOVAQUONE
Active Ingredient Strength750 mg/5mL
Pharm ClassesAntimalarial [EPC],Antiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66689-062-18

18 POUCH in 1 CASE (66689-062-18) > 1 mL in 1 POUCH (66689-062-01)
Marketing Start Date2018-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66689-062-01 [66689006201]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA202960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-14

NDC 66689-062-18 [66689006218]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA202960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-14

NDC 66689-062-42 [66689006242]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA202960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-14

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE750 mg/5mL

OpenFDA Data

SPL SET ID:c61aa490-5b55-4ba9-b107-bb37f1fa352b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308429

    • Pharmacological Class

    • Antimalarial [EPC]
    • Antiprotozoal [EPC]

    NDC Crossover Matching brand name "Atovaquone" or generic name "Atovaquone"

    NDCBrand NameGeneric Name
    0121-0888AtovaquoneAtovaquone
    0121-0898AtovaquoneAtovaquone
    0121-1796AtovaquoneAtovaquone
    0904-7064AtovaquoneAtovaquone
    16714-900atovaquoneatovaquone
    31722-629AtovaquoneAtovaquone
    50268-086AtovaquoneAtovaquone
    51407-642AtovaquoneAtovaquone
    60687-534AtovaquoneAtovaquone
    65162-693ATOVAQUONEATOVAQUONE
    66689-062AtovaquoneAtovaquone
    66993-062Atovaquoneatovaquone
    68180-282AtovaquoneAtovaquone
    68462-421atovaquoneatovaquone
    70166-488AtovaquoneAtovaquone
    10702-223Atovaquone Oral SuspensionAtovaquone
    0173-0547MEPRONatovaquone
    0173-0665MEPRONatovaquone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.