NDC 57297-723

Cefdinir

Cefdinir

Cefdinir is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Lupin Limited. The primary component is Cefdinir.

Product ID57297-723_231debe8-1d48-478f-adfd-8bf7f50c0088
NDC57297-723
Product TypeHuman Prescription Drug
Proprietary NameCefdinir
Generic NameCefdinir
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2007-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA065259
Labeler NameLUPIN LIMITED
Substance NameCEFDINIR
Active Ingredient Strength250 mg/5mL
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-723-10

100 mL in 1 BOTTLE (57297-723-10)
Marketing Start Date2007-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-723-20 [57297072320]

Cefdinir POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065259
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-01
Inactivation Date2020-01-31

NDC 57297-723-10 [57297072310]

Cefdinir POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065259
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFDINIR250 mg/5mL

OpenFDA Data

SPL SET ID:11c56998-b4d4-48d9-99b0-ecaeba7ec54c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476576
  • 309054
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefdinir" or generic name "Cefdinir"

    NDCBrand NameGeneric Name
    0093-3160CefdinirCefdinir
    0093-4136CefdinirCefdinir
    0093-4137CefdinirCefdinir
    0781-2176CefdinirCefdinir
    0781-6077CefdinirCefdinir
    0781-6078CefdinirCefdinir
    10544-194CefdinirCefdinir
    16714-391CefdinirCefdinir
    16714-392CefdinirCefdinir
    16714-393CefdinirCefdinir
    17856-1150CefdinirCefdinir
    21695-620CefdinirCefdinir
    21695-622CefdinirCefdinir
    33261-905CefdinirCefdinir
    42043-250CefdinirCefdinir
    42043-251CefdinirCefdinir
    42043-252CefdinirCefdinir
    42254-127CefdinirCefdinir
    42254-177CefdinirCefdinir
    43063-466CefdinirCefdinir
    43063-597CefdinirCefdinir
    43063-852CefdinirCefdinir
    43063-853CefdinirCefdinir
    43063-959CefdinirCefdinir
    68001-150CefdinirCefdinir
    68001-362CefdinirCefdinir
    68071-1788CefdinirCefdinir
    68071-3156CefdinirCefdinir
    68071-4007CefdinirCefdinir
    68071-3032CefdinirCefdinir
    68071-3393CefdinirCefdinir
    68071-4236CefdinirCefdinir
    68071-3295CefdinirCefdinir
    68071-4419CefdinirCefdinir
    68071-4792CefdinirCefdinir
    68180-723CefdinirCefdinir
    68258-3053CefdinirCefdinir
    68180-711CefdinirCefdinir
    68180-722CefdinirCefdinir
    68788-6840CefdinirCefdinir
    68788-7062CefdinirCefdinir
    68788-7111CefdinirCefdinir
    68788-7255CefdinirCefdinir
    68788-7339CefdinirCefdinir
    68788-7375CefdinirCefdinir
    68788-9760CefdinirCefdinir
    70518-1213CefdinirCefdinir
    70934-062CefdinirCefdinir
    70934-164CefdinirCefdinir
    70934-044CefdinirCefdinir

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