NDC 52565-053

CEFOTAN

Cefotetan Disodium

CEFOTAN is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Cefotetan Disodium.

Product ID52565-053_675e1e86-13c2-4287-b4ed-cc60d01b9acc
NDC52565-053
Product TypeHuman Prescription Drug
Proprietary NameCEFOTAN
Generic NameCefotetan Disodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2015-10-01
Marketing CategoryNDA / NDA
Application NumberNDA050588
Labeler NameTeligent Pharma, Inc.
Substance NameCEFOTETAN DISODIUM
Active Ingredient Strength2 g/20mL
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52565-053-10

10 VIAL in 1 TRAY (52565-053-10) > 20 mL in 1 VIAL
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-053-10 [52565005310]

CEFOTAN INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050588
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-01

Drug Details

Active Ingredients

IngredientStrength
CEFOTETAN DISODIUM2 g/20mL

OpenFDA Data

SPL SET ID:0860bfe0-da3e-4460-da57-2411db14c426
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1722919
  • 1731542
  • 1743557
  • 1722921
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]
    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

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

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

    Trademark Results [CEFOTAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CEFOTAN
    CEFOTAN
    98044443 not registered Live/Pending
    PAI Holdings, LLC
    2023-06-15
    CEFOTAN
    CEFOTAN
    86441285 5096017 Live/Registered
    TELIGENT, INC.
    2014-10-31
    CEFOTAN
    CEFOTAN
    77095322 not registered Dead/Abandoned
    Astellas Pharma Inc.
    2007-01-31
    CEFOTAN
    CEFOTAN
    73431446 1366244 Dead/Cancelled
    YAMANOUCHI PHARMACEUTICAL CO., LTD.
    1983-06-22

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