NDC 63323-396

Cefotetan

Cefotetan Disodium

Cefotetan is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cefotetan Disodium.

Product ID63323-396_fe9acb9a-bea1-4f7e-a512-a089a642151e
NDC63323-396
Product TypeHuman Prescription Drug
Proprietary NameCefotetan
Generic NameCefotetan Disodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA065375
Labeler NameFresenius Kabi USA, LLC
Substance NameCEFOTETAN DISODIUM
Active Ingredient Strength10 g/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-396-61

1 VIAL in 1 BOX (63323-396-61) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Marketing Start Date2009-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-396-61 [63323039661]

Cefotetan INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065375
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-03
Marketing End Date2018-09-30

Drug Details

Active Ingredients

IngredientStrength
CEFOTETAN DISODIUM10 g/1

OpenFDA Data

SPL SET ID:c6b8667e-8bb6-ea58-a969-2f74458bc611
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1722916

    • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefotetan" or generic name "Cefotetan Disodium"

    NDCBrand NameGeneric Name
    0143-9670CefotetanCefotetan
    0143-9671CefotetanCefotetan
    63323-385CefotetanCEFOTETAN DISODIUM
    63323-386CefotetanCEFOTETAN DISODIUM
    63323-396CefotetanCEFOTETAN DISODIUM
    52565-052CefotanCefotetan Disodium
    52565-053CEFOTANcefotetan disodium
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