NDC 70166-488

Atovaquone

Atovaquone

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

Product ID70166-488_9a19deb0-f27c-b93d-e053-2a95a90aa48b
NDC70166-488
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone
Generic NameAtovaquone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-10-11
Marketing CategoryANDA / ANDA
Application NumberANDA210692
Labeler NameLohxa
Substance NameATOVAQUONE
Active Ingredient Strength750 mg/5mL
Pharm ClassesAntimalarial [EPC],Antiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70166-488-05

50 CUP, UNIT-DOSE in 1 CARTON (70166-488-05) > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2018-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70166-488-05 [70166048805]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA210692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-03

NDC 70166-488-10 [70166048810]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA210692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-03

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE750 mg/5mL

OpenFDA Data

SPL SET ID:ba3cad0d-cce9-424f-ba5c-557dba8bef12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308429
  • UPC Code
  • 0370166488050
  • 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

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