NDC 0121-0888

Atovaquone

Atovaquone

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

Product ID0121-0888_a3e3f2d4-b701-3974-e053-2a95a90a63b7
NDC0121-0888
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone
Generic NameAtovaquone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-11-07
Marketing CategoryANDA / ANDA
Application NumberANDA209105
Labeler NamePharmaceutical Associates, Inc.
Substance NameATOVAQUONE
Active Ingredient Strength750 mg/5mL
Pharm ClassesAntimalarial [EPC],Antiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0121-0888-18

3 TRAY in 1 CASE (0121-0888-18) > 6 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0888-05)
Marketing Start Date2020-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0888-42 [00121088842]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA209105
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 0121-0888-05 [00121088805]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA209105
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07

NDC 0121-0888-18 [00121088818]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA209105
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE750 mg/5mL

OpenFDA Data

SPL SET ID:03a3ddba-6d0a-4cda-8013-bdd7afb351ea
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
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