NDC 10544-194

Cefdinir

Cefdinir

Cefdinir is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Cefdinir.

Product ID10544-194_1181a59e-a434-20d0-e054-00144ff88e88
NDC10544-194
Product TypeHuman Prescription Drug
Proprietary NameCefdinir
Generic NameCefdinir
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA065434
Labeler NameBlenheim Pharmacal, Inc.
Substance NameCEFDINIR
Active Ingredient Strength300 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-194-20

20 CAPSULE in 1 BOTTLE (10544-194-20)
Marketing Start Date2013-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-194-20 [10544019420]

Cefdinir CAPSULE
Marketing CategoryANDA
Application NumberANDA065434
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFDINIR300 mg/1

OpenFDA Data

SPL SET ID:1181a59e-a433-20d0-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200346
  • 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

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