NDC 0781-5438

Cefpodoxime Proxetil

Cefpodoxime Proxetil

Cefpodoxime Proxetil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Cefpodoxime Proxetil.

Product ID0781-5438_498cba4e-97e4-44c6-bd22-e6ee3942db51
NDC0781-5438
Product TypeHuman Prescription Drug
Proprietary NameCefpodoxime Proxetil
Generic NameCefpodoxime Proxetil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA065462
Labeler NameSandoz Inc
Substance NameCEFPODOXIME PROXETIL
Active Ingredient Strength100 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-5438-01

100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01)
Marketing Start Date2008-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5438-20 [00781543820]

Cefpodoxime Proxetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-28

NDC 0781-5438-01 [00781543801]

Cefpodoxime Proxetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065462
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-28

Drug Details

Active Ingredients

IngredientStrength
CEFPODOXIME PROXETIL100 mg/1

OpenFDA Data

SPL SET ID:8519a9d8-7106-4545-bc58-859ee9a6708e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309078
  • 309076
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefpodoxime Proxetil" or generic name "Cefpodoxime Proxetil"

    NDCBrand NameGeneric Name
    0781-5438Cefpodoxime ProxetilCefpodoxime Proxetil
    0781-5439Cefpodoxime ProxetilCefpodoxime Proxetil
    0781-6168Cefpodoxime ProxetilCefpodoxime Proxetil
    0781-6169Cefpodoxime ProxetilCefpodoxime Proxetil
    16714-394CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    16714-395CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    16714-402Cefpodoxime ProxetilCefpodoxime Proxetil
    16714-403Cefpodoxime ProxetilCefpodoxime Proxetil
    26637-711Cefpodoxime ProxetilCefpodoxime Proxetil
    26637-712Cefpodoxime ProxetilCefpodoxime Proxetil
    42043-120Cefpodoxime ProxetilCefpodoxime Proxetil
    42043-121Cefpodoxime ProxetilCefpodoxime Proxetil
    52343-019CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    52343-020CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    64980-402Cefpodoxime ProxetilCefpodoxime Proxetil
    64980-403Cefpodoxime ProxetilCefpodoxime Proxetil
    65862-095CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    65862-096CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    69043-007CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    69043-006CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
    65862-141Cefpodoxime ProxetilCefpodoxime Proxetil
    65862-140Cefpodoxime ProxetilCefpodoxime Proxetil

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.